Phase 3 Clinical Trial Investigating The Need For Stem Cell Transplantation Is Recruiting Myeloma Patients – Newly diagnosed multiple myeloma patients under the age of 65 years are being recruited at various cancer centers across the United States for a Phase 3 clinical trial that will investigate whether stem cell transplants are necessary in the era of novel agents.  All participants will be treated with a combination of Revlimid (lenalidomide), Velcade, and dexamethasone.  Half of the patients will then also receive a stem cell transplant.  Based on the results, researchers will determine whether stem cell transplanta­tion sig­nificantly extends progression-free survival. For more information or to enroll, please see the clinical trial description.

Teleconference On Clinical Trial Participation – On Thursday, the International Myeloma Foundation will sponsor a teleconference about the importance of participating in clinical trials.  Dr. Brian Durie, a myeloma specialist at Cedars-Sinai Cancer Center, will discuss the Phase 3 clinical trial comparing carfilzomib-Revlimid-dexamethasone and Revlimid-dexamethasone alone.  The call will be held from 4 p.m. to 5 p.m. PT.  For more information, please see the International Myeloma Foundation website.

For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.

Senesco Technologies And Mayo Clinic To Begin Clinical Trial Of SNS01-T For Myeloma – On August 24, Senesco Technologies announced an agreement with the Mayo Clinic to conduct a clinical trial to study SNS01-T, an investigational drug that Senesco is developing for multiple myeloma. The trial will assess the safety, tolerability, and efficacy of SNS01-T in relapsed as well as refractory multiple myeloma patients. The trial is expected to start by the end of September.  For more information, please see the Senesco website.

Retaspimycin Shows Modest Activity In Phase 1 Trial For Myeloma – Results from a Phase 1 clinical trial showed that retaspimycin hydrochloride (IPI-504), an investigational drug being developed by Infinity Pharmaceuticals, has modest activity in relapsed and refractory multiple myeloma patients. Retaspimycin stabilized disease in four of eighteen patients participating in the trial. The most common side effect was pain at the infusion site.  All side effects were mild or moderate. For more information, see the study in the journal Leukemia and Lymphoma (abstract).

Boston Workshop For Multiple Myeloma Patients – The Multiple Myeloma Research Foundation (MMRF) will hold a one-day workshop for myeloma patients and their families on September 9 in Boston. Dr. Paul Richardson, a myeloma expert from the Dana-Farber Cancer Institute, will lead the program. Throughout the day, myeloma experts will talk about prognosis, treatments for newly diagnosed and relapsed/refractory patients, supportive care options, and clinical trials. The specialists will also be available to answer questions. Registration will begin at 9 a.m., and the program will run from 10 a.m. until 3.30 p.m. at the Westin Copley Place. For more information or to register, please see the MMRF website.

For a more detailed list of myeloma-related events, please see the Myeloma Beacon Events Calendar.

More than 30,000 clinical specialists from all over the world are expected to attend the five-day meeting to discuss the current research in cancer treatment and care. This year’s meeting will primarily focus on the theme of “Patients, Pathways, Progress.”

The meeting will include many presentations and seminars focused specifically on multiple myeloma. The ASCO website currently lists over 40 myeloma-based abstracts.

The Myeloma Beacon will be covering the meeting, so readers can expect many articles during and after the meeting about the key myeloma findings.

At the meeting, Dr. Kenneth Anderson from the Dana-Farber Cancer Center will receive the David A. Karnofsky Memorial Award, which recognizes “innovative clinical research and developments that have changed the way oncologists think about the general practice of oncology.”  He is being honored for his achievements in myeloma research, including his studies on novel therapies that have helped transform myeloma therapy.

Treatments Under Development

Several of this year’s ASCO presentations will unveil results from Phase 1 and Phase 2 clinical trials of drugs under development for the treatment of multiple myeloma. In particular, there will be many presentations on carfilzomib, pomalidomide, elotuzumab, panobinostat, and several newer drugs that are in the early stages of clinical testing.

During a poster session on June 4, results will be presented from four Phase 2 clinical trials of carfilzomib for relapsed / refractory (resistant) myeloma.  These studies include a clinical trial of single-agent carfilzomib, a study of carfilzomib in combination with Revlimid (lenalidomide) and dexamethasone (Decadron), a study of carfilzomib in patients who have never been treated with Velcade (bortezomib), and a study of carfilzomib in combination with current myeloma treatments.  There will also be a poster on June 5 about an ongoing Phase 3 study comparing carfilzomib, Revlimid, and dexamethasone therapy to Revlimid and dexamethasone without carfilzomib.

On June 5, there will be three oral presentations about potential new anti-myeloma drugs.

First, Dr. Noopur Raje will present results from a Phase 1 study evaluating the optimal dosage for LY2127399 (a human antibody that has shown anti-myeloma activity) when given in combination with Velcade to previously treated myeloma patients.  Results indicate that more than 50 percent of patients may respond to this therapy.

Next, Dr. Jesus Berdeja will present results from a Phase 1 study of lorvotuzumab mertansine in combination with Revlimid and dexamethasone in a specific subset of relapsed / refractory myeloma patients whose myeloma cells contain the CD56 protein.  Preliminary results indicate that about 50 percent of the study participants may respond to this combination therapy.  Updated results will be presented at the meeting.

Then Dr. Paul Richardson will present a Phase 2 study that found the combination of elotuzumab, Revlimid, and dexamethasone to be active and well tolerated in relapsed myeloma patients.  Preliminary results indicate that 80 percent to 90 percent of myeloma patients may respond to this therapy. Results from the Phase 1 study will be presented in a poster session on June 6.  There will also be a poster presentation about elotuzumab’s effect on natural killer cells, which are immune cells that kill cancer cells.

During a poster session on June 6, researchers will present the results of a Phase 2 study evaluating the combination of pomalidomide plus dexamethasone in myeloma patients previously treated with Revlimid.  Preliminary results show that about 35 percent of patients previously treated with Revlimid respond to pomalidomide.

There will also be poster presentations about a Phase 1b study of panobinostat and Velcade and an ongoing Phase 3 study of panobinostat, Velcade, and dexamethasone, both in relapsed / refractory patients.

Additionally, results from a Phase 1 study of GDC-0941 will be presented during a poster session.  GDC-0941 is an oral phosphoinositide-3 kinase inhibitor.  The study tested the drug in patients with myeloma or an advanced solid tumor.

Revlimid And Secondary Cancers

A section of the oral session on June 5 will focus on the risk of developing secondary cancers after treatment with Revlimid. The U.S. Food and Drug Administration recently announced that it is currently investigating whether long-term use of Revlimid  increases a patient’s risk of developing a second cancer (see related Beacon news).

During the session, Dr. Antonio Palumbo will present the latest secondary cancer data from his study in which newly diagnosed, elderly myeloma patients were treated with melphalan (Alkeran) and prednisone with or without co-administration of Revlimid, followed by Revlimid maintenance.

Dr. Adrianna Rossi will then present data on the rate of secondary cancers six years after newly diagnosed myeloma patients were treated with Revlimid.

Then Dr. Meletios Dimopoulos will present secondary cancer data from two studies in which relapsed and/or refractory patients received Revlimid plus dexamethasone or a placebo plus dexamethasone.

Afterward, Dr. Ola Landgren will lead a discussion on the topic.

Bisphosphonates

This year’s ASCO oral session on myeloma will include presentations about bisphosphonates and their ability to treat myeloma bone disease as well as their potential beneficial impact on survival. Although bisphosphonates are currently the gold-standard treatment for myeloma bone disease, recent results from clinical studies have suggested that even myeloma patients without bone disease may benefit from treatment with bisphosphonates.

Dr. Kevin Boyd will present results from a study that evaluated the ability of Zometa (zoledronic acid) to reduce skeletal-related events and improve progression-free survival in myeloma patients both with and without bone disease. In another presentation about the same study, Dr. Faith Davies will discuss the impact of Zometa and Bonefos (clodronate) on survival times for newly diagnosed myeloma patients.

After these two talks, Dr. David Roodman will lead a discussion on the topic.

For more information on ASCO’s 47th Annual Meeting, including presentation abstracts, the final schedule, and information on attending, please see the American Society of Clinical Oncology meeting website.

National Cancer Institute To Begin Phase 1 Study Of Reolysin For Multiple Myeloma – Oncolytics Biotech, the company developing the drug Reolysin, recently announced plans for a Phase 1 clinical trial investigating the effectiveness of Reolysin in relapsed multiple myeloma patients. Reolysin is a formulation of a common human virus that is able to infect and kill certain cancer cells, including myeloma cells. The study is sponsored by the Cancer Therapy Evaluation Program of the U.S. National Cancer Institute and is not yet recruiting participants. For more information, please see the Oncolytics press release.

Multiple Myeloma Education Programs – Two educational programs for multiple myeloma patients will be held on May 21. Dr. Robert Vescio will speak at the event held in Riverside, CA, and Dr. Ruben Niesvizky will speak at the event in Albany, NY. The physicians will also answer patients’ questions. In addition, a multiple myeloma patient will speak at each program. Attendees can also connect with others at the event who have been affected by myeloma. Both events are sponsored by Millennium. For more information, please see the Beacon event descriptions (Riverside, Albany). To register, call 1-866-508-6181.

For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.

This article is the second part of a two-part series based on The Myeloma Beacon’s interview with Dr. Anderson.  It will cover Dr. Anderson’s thoughts on where myeloma treatment is headed in the coming years.  For more information on Dr. Anderson’s current approach to treating multiple myeloma, please see part one of this series.

Emerging Therapies

According to Dr. Anderson, there are several promising agents being developed to treat multiple myeloma.

The first promising agent that he discussed was carfilzomib, a proteasome inhibitor like Velcade (bortezomib).  “Carfilzomib appears to be active in relapsed myeloma and very well tolerated with very little in the way of neuropathy [pain or tingling in the extremities],” Dr. Anderson explained.

He was also impressed with pomalidomide’s potential.  Pomalidomide is an immunomodulatory drug like thalidomide (Thalomid) and Revlimid (lenalidomide).  “Pomalidomide, like thalidomide and Revlimid, targets the tumor in the microenvironment, but excitingly pomalidomide is active even when thalidomide and Revlimid are not.  Pomalidomide is also active when Velcade is not.”

Besides these two investigational drugs, Dr. Anderson saw the most potential in combinations of treatments.

Dr. Anderson mentioned combinations of Velcade and a histone deacetylase inhibitor, either Zolinza (vorinostat) or panobinostat, which have achieved responses in the majority of patients who have not responded to Velcade.

He also felt that Velcade in combination with the AKT inhibitor perifosine appears to be effective in patients who have previously been treated with or did not respond to Velcade.

In combination with Revlimid and dexamethasone (Decadron), Dr. Anderson was most excited about the addition of the antibody elotuzumab.  He said that this combination has achieved a very high response rate in myeloma patients.

Personalized Therapy

In the next several years, Dr. Anderson thinks that personalized therapy for multiple myeloma patients will become more and more common.

He explained that myeloma patients can be treated differently based on their genetic profile.  However, he said, “We first need to be better able to profile patients to determine who is likely to respond to which treatment; and secondly, personalized medicine in myeloma will require us to develop more targeted therapies.”

If advances are made in these two areas, Dr. Anderson said, “I would think over the next three to five years that personalized treatments will occur.”

Myeloma Stem Cells

In the coming years, myeloma specialists also hope to better understand myeloma stem cells, the cancerous cells that reproduce and may be responsible for relapse of the disease.

“So far, we have not been able to reproducibly identify that stem cell, but there is great emphasis on trying to understand its biology so we can effectively target it,” said Dr. Anderson.  “Ultimately, in order for cure to occur, the ability for myeloma to return and cause relapse will have to be overcome.”

Cure For Myeloma

Many myeloma specialists differ in opinion about the goal of treating multiple myeloma patients.

For some, the goal is to cure myeloma patients by achieving and maintaining a complete response or eliminating all traces of myeloma.  Others argue that the aggressive treatment needed to nearly wipe out the myeloma cells can severely impact a patient’s quality of life, and yet the patient is still likely to relapse.  Many of these physicians would prefer to get the disease to a safe level and then treat to control the disease while maintaining a high quality of life for the patient.

When asked his opinion in the debate, Dr. Anderson replied, “Absolutely, the goal should be to cure our patients.”

“I strongly think that in the era of novel therapies, used in combination and as maintenance, sustained complete responses will be achievable in the majority of patients,” said Dr. Anderson. “First achieving complete responses and then sustaining those complete responses is, in fact, the pathway towards cure, and I do think we’re closer to that goal than ever before.”

Dr. Anderson said that this approach does not have to significantly impact quality of life.  “Quality of life is obviously paramount and of the highest importance,” he said. “The good news is that novel therapies used appropriately really are also very well tolerated.”

“I don’t think it needs to be one or the other.  I think we can actually achieve high response rates, and fortunately, they are associated not only with living longer, but living longer with a quality life,” he added.

Advancing Research Through Clinical Trials

Dr. Anderson said that the quickest way for advances to be made in the treatment of myeloma is for patients to participate in clinical trials.  “I would most enthusiastically urge patients to endorse the concept of clinical trials and ask patients to participate whenever possible.”

He said patients should participate because “you will get top notch, cutting edge, novel treatments that will give you the best possible chance for doing well in myeloma.”

For those who are concerned about randomized clinical trials, in which half of the patients receive the standard of care instead of the study drug, Dr. Anderson said, “We don’t know which of the options are better.  Usually in a randomized trial, there is the opportunity later on to receive the treatment that you were not chosen to receive if it in fact is beneficial.  In other words, a patient often ends up receiving the new medicine either right away or later.”

Dr. Anderson concluded by saying, “I think it’s a very exciting time in myeloma, and it’s a unique privilege for all of us to help, together with our patients, improve the outcome in this disease.”

For more information about Dr. Anderson’s approach to treating multiple myeloma, please see part one of this series.

Compared to conventional chemotherapy, stem cell transplantation helped the patients with t(4;14) achieve higher-quality responses. However, most patients continued to experience quick and aggressive relapses after stem cell transplantation.

The study authors indicated the need for investigation into consolidation and maintenance strategies that would slow down the rapidity and severity of relapses after remission.

Approximately 15 percent of multiple myeloma patients have the t(4;14) abnormality, a translocation of a region of chromosome 4 to chromosome 14. This abnormality is associated with poor overall survival in myeloma patients.

The chromosomal condition is also evident in a large number of patients with multiple myeloma precursor diseases, but according to Dr. S. Vincent Rajkumar, Professor of Medicine at Mayo Clinic in Rochester, Minnesota, “There is no data that patients with t(4;14) [precursor diseases] have a higher risk of progression to myeloma.”

To evaluate the prognosis of t(4;14) patients, researchers studied 102 myeloma patients with t(4;14). The median age of the patients included in the study was 56 years. Seventy-six patients had symptomatic myeloma, and 26 had a symptom-free precursor of myeloma.

Fifty-six of the 76 patients with symptomatic myeloma received high-dose melphalan with stem cell transplantation after three to four months of less intensive initial treatment. Of the 46 patients who did not undergo stem cell transplantation, 26 received conventional chemotherapy.

Ninety-three percent of the patients who received a stem cell transplant responded to the treatment, with 66 percent achieving either a complete response or a very good partial response.

Of the patients who received conventional chemotherapy, 60 percent of patients responded, with 8 percent achieving a very good partial response. None of the patients experienced a complete response.

The median progression-free survival for stem cell transplantation and conventional chemotherapy patients was 12 months and 11 months, respectively.

Within a 36-month median follow-up period, 64 patients relapsed (41 patients after stem cell transplantation and 23 after conventional chemotherapy). Thirty-seven percent of relapsed patients experienced aggressive features, such as acute kidney failure, high calcium levels in the blood, tumors outside the bone marrow, and fluid build-up around the lungs.

All relapsed patients received a rescue treatment. The rescue treatment succeeded in 51 percent of patients who relapsed after stem cell transplantation. Seventy-six percent of patients responded to a Velcade (bortezomib)-based rescue treatment, compared to 31 percent of patients who received thalidomide (Thalomid) or Revlimid (lenalidomide). Patients who received Velcade achieved a median progression-free survival of 6.9 months, compared to 3.2 months for patients who received thalidomide or Revlimid.

However, the researchers did not observe any difference in effectiveness between Velcade and thalidomide or Revlimid for patients who received conventional chemotherapy; a 26 percent response rate and a median progression-free survival of 6.5 months occurred for these patients receiving any of the rescue treatments.

The median overall survival was 31 months for patients who received a stem cell transplant, compared to 26 months for patients who received conventional chemotherapy. The median progression-free survival advantage that the researchers observed for stem cell transplant patients who received Velcade as rescue treatment compared to patients who received thalidomide or Revlimid did not translate into a significant overall survival advantage.

To improve the prognosis for patients with t(4;14), Dr. Rajkumar, who was not involved in the study, suggested focusing research on initial therapy. “Data from the University of Arkansas for Medical Sciences shows that with aggressive Velcade-based initial therapy, transplant, and then Velcade-based maintenance, survival of [patients with] t(4;14) can be similar to [those with] standard-risk myeloma,” Dr. Rajkumar told The Myeloma Beacon.

“Other studies do not show such a dramatic improvement, but do show a benefit with Velcade-based initial therapy,” he added.

For more information, please see the article in Leukemia and Lymphoma (abstract).

Cancer patients know they have a potentially terminal illness, have often failed first and second therapies, and are desperate for better treatment of their disease.  Why wouldn’t they be clamoring to join trials in large numbers?  Assuming they meet inclusion criteria, why wouldn’t the vast majority be anxious to participate?

Without answering those basic questions and making the process more focused on the needs of patients, clinical trials will continue to get inadequate accrual numbers.

One would think that the immediate intent of clinical trials is to help patients, but that is not correct.  Trials are performed to answer specific scientific questions.  It is wonderful if patients are helped, but the purpose of any given trial is to obtain a statistically valid answer to the question raised.

By the time cancer patients have failed their first or second courses of therapy, most have a good understanding of their cancer.  They have searched the Internet, sought second opinions, and have definite ideas about their next potential treatment.  These educated patients should be prime candidates for clinical trials.

Suppose a patient truly researched a potential new treatment and has found a trial utilizing the new agent.  In discussing it with the principle investigator, imagine their profound disappointment when he tells them they have a 50/50 chance of getting the experimental treatment or the standard treatment for their second or third relapse.  The principle investigator patiently explains that no one knows which arm of the trial will do better.  In his heart of hearts, however, he has his opinion, and so does the patient.

Whether it is right or not, the patient has an opinion and that opinion should have standing! Give patients all known information to date regarding the experimental treatment, and let them decide which arm they want to be part of.  Accrual numbers will increase dramatically with patients who finally feel empowered with some degree of control over the cancer inside them.

Yes, I know that is statistical blasphemy.  Anything less than the gold standard, the randomized clinical trial, would not count as a proper trial.  Bias would make the whole trial suspect or worthless. The trial would not have statistical validity.   I have heard this answer dozens of times.

I have also watched dozens of good trials close early because they did not attract patients.  At the 2010 American Society of Hematology meeting, there were at least 10 promising new agents for myeloma, but there are not enough patients attracted to the clinical trial process to even test these treatments.

As it is now, patients are left with the feeling that their clinician is offering them a choice of treatments based on no more than a coin flip—which is exactly what he or she is doing.  When patients have strong feelings about what they want for their next course of therapy, it is no wonder that they are completely turned off by such an approach.

Cancer patients are more than experimental “subjects.”  They are not lab animals who have no reasoning ability, but are humans who should be allowed to make their own value decisions—right or wrong.

Some patients will be willing to accept side effects and potential unknowns of the new experimental treatment.  Others, however, will be quite content to be in the control arm and ‘stay with what is known.’

The decisions of both groups should be accepted, and their numbers should be added to the corresponding trial arms.  After their choice of arm, they should be treated and followed just as if they had been randomized by computer.

Statisticians will cringe and say the whole trial is worthless, despite the fact that accrual numbers would soar.

Consider, however, the woeful ineffectiveness of our current clinical trial system.  What good is a statistically perfect, well-designed trial if nobody shows up?  Our current system is broken and needs new approaches to randomize patients based on their informed right to choose their own treatment.  This profound decision affects their life and their cancer.  Treatment should be their choice.

Having personally known myeloma for 13 years, I have definite opinions regarding what my treatment course number 5 will be when it is time to make that decision.  Like so many of my fellow patients (97 percent), I would refuse to be randomized and leave this life-and-death decision to the flip of a coin.

To all who denounce such an unscientific approach, please outline an improved system based on a patient’s absolute right to choose his treatment.  We can ‘think outside the box’ and use a different approach, or we can keep the same system and get the same results—3 percent participation with many drop-outs.  Without a change, we will continue to observe that only a tiny minority of clinical trials open, accrue, close, and are reported in a timely manner with useful information for clinicians and cancer patients.

Statisticians can take nearly any set of numbers, apply their formulas, and make pronouncements regarding those numbers.  I contend that they can also devise statistical systems that provide relevant answers to outcomes of trials that are based on the right of cancer patients to choose their own treatments.

Jim Omel MD is a retired family physician and 13+ year myeloma survivor who is active in many areas of cancer patient advocacy.

A key factor in this decision, according to the company, was that it no longer feels the drug offers an adequate efficacy / safety trade-off as a potential treatment for multiple myeloma.

Earlier this year, Glaxo suspended its Phase 2 trial of SRT501 in multiple myeloma because several patients in the trial developed kidney failure.

At the time, it was unclear if the kidney failure cases were due to SRT501, or if they were a natural consequence of the patients’ multiple myeloma. The form of kidney failure that was observed – cast nephropathy – is a common complication of multiple myeloma, so much so that it is often described as “myeloma kidney.”

According to a GlaxoSmithKline spokesperson, an internal analysis of the kidney failure cases has concluded that they “most likely were due to the underlying disease … However, the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute [kidney] failure.”

For this reason, the company decided to terminate the Phase 2 trial of SRT501 in multiple myeloma and halt development of the drug as a potential myeloma treatment. The SRT501 formulation of resveratrol “may only offer minimal efficacy,” explained the Glaxo spokesperson, while increasing the chances of kidney failure.

It is currently uncertain why GlaxoSmithKline decided to terminate all further development of SRT501.  The company could have ended trials of the drug as a possible myeloma treatment, but continued to test the drug in trials for other diseases.  [See Update #2 below.]

The resveratrol in SRT501 is from a plant-based source. It is micronized, or milled into very small uniform particles, to maximize uptake into the body. Patients in the SRT501 multiple myeloma trial received a relatively high dose of resveratrol – 5 grams of SRT501 – once per day.

Resveratrol is a molecule found in small quantities in the skin of red grapes and in red wine. It is thought to be the source of red wine’s reported health benefits.

Previous studies have indicated that resveratrol may be effective at killing cancer cells, including multiple myeloma cells.

Scientific evidence for these claims has been controversial and confined mostly to the laboratory. The SRT501 trial was the first attempt to determine the effectiveness of resveratrol in treating multiple myeloma patients.

Update #1 (November 30, 2010; 4:10 pm) –  The full text of GlaxoSmithKline’s statement to The Myeloma Beacon regarding its decision to halt further development of SRT501 is as follows:

GSK will terminate its phase IIa study of SRT501 in advanced multiple myeloma. We have taken this decision following a comprehensive analysis of the data which suggested this formulation of resveratrol may only offer minimal efficacy while having a potential to indirectly exacerbate a renal complication  common in this patient population.

This same analysis also reviewed the cases of acute renal failure in five study patients, which had triggered the suspension of new patient enrolment in April this year. This analysis concluded that these renal failure cases were most likely due to the underlying disease, as kidney complications related to myeloma occur in up to 50% of cases. However, the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute renal failure.

Investigators and regulators in the UK and Denmark, where the study was being conducted, were consulted on the analysis of the data and unanimously supported the decision to terminate the trial at this time.  There are no further plans to develop SRT501.

Update #2 (November 30, 2010; 5:30 pm) – In a separate statement to The Myeloma Beacon, a Glaxo spokesperson explained the rationale for the company’s decision to halt all development of SRT501.  Ending all work on SRT501, the spokesperson said, will allow Glaxo to focus its resources on the development of drugs that act similarly to SRT501, but have more favorable properties.  The spokesperson mentioned, in particular, SRT2104 and SRT2379 as drugs similar to SRT501 that the company is developing. Neither of these drugs, however, is currently being tested as a potential treatment for multiple myeloma.

The full Glaxo statement to the Beacon on this matter was as follows: ”We are focusing our efforts now on more selective SIRT1 activator compounds that have no chemical relationship to SRT501 and more favorable drug-like properties.  Currently we have two of these latest generation compounds (SRT2104 and SRT2379) in several exploratory clinical trials.”

Phase 2 Trials Of IPH 2101 Are Recruiting Myeloma And Smoldering Myeloma Patients – Several Phase 2 clinical trials are now recruiting multiple myeloma and smoldering multiple myeloma patients to receive the experimental agent IPH 2101 (anti-KIR). IPH 2101 is an antibody drug being developed by Innate Pharma. It helps activate cells of the immune system to destroy cancer cells. IPH 2101 is being studied in patients with smoldering myeloma to see if it delays and/or prevents progression to multiple myeloma (trial description). It is also being studied in multiple myeloma patients in stable partial response after a first line therapy (trial description) and in combination with Revlimid (lenalidomide) in myeloma patients experiencing their first relapse (trial description). To participate in the smoldering myeloma trial at the National Institutes of Health, please contact the research nurse, Mary Ann Yancey, at (301) 435-9227 or .

Phase 3 Double Transplant Trial Is Currently Recruiting Myeloma Patients – Myeloma patients are now being recruited by the Hackensack University Medical Center in New Jersey to participate in a Phase 3 trial of tandem stem cell transplants with melphalan (Alkeran) followed by melphalan and Velcade (bortezomib). The purpose of this trial is to determine if the addition of Velcade to the second transplant will increase remission times. For more information, please see the clinical trial description.

Senesco Plans Phase 1/2 Study Of SNS01-T – Senesco Technologies, a biotechnology company, announced plans to file by the end of 2010 for approval of a Phase 1a/2b study of SNS01-T in multiple myeloma patients. SNS01-T has shown promising results in mice. If approved, the trial will begin in the first half of 2011. For more information, please see the Senesco press release.

International Society Of Hematology Congress – The International Society of Hematology will hold its 33rd annual congress in Jerusalem between October 10 and 13. Hematologists from around the world will gather to discuss the latest research, therapies, and tools available in the field. For more information, please see the Hematology Congress 2010 website.

Clinical Insights Educational Program – Dr. Robert Orlowski of the MD Anderson Cancer Center will be chairing an educational program in Houston on October 15. The program will feature seminars by some of the leading myeloma researchers, including Drs. Kenneth Anderson, Sagar Lonial, William Bensinger, Nikhil Munshi, and Irene Ghobrial. Seminar topics include front-line therapy, stem cell transplant, relapsed/refractory disease, supportive care, and clinical trials. The program will close with a question and answer panel by the faculty. For more information, please see the Multiple Myeloma Research Foundation website.

For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.