| '  A recent study suggests that the addition of defibrotide to the combination regimen of melphalan (Alkeran), prednisone, and thalidomide (Thalomid) may result in fewer side effects in multiple myeloma patients. The Phase 1 clinical trial results were recently published in the journal Haematologica. With the development of multiple myeloma therapies, the traditional melphalan-prednisone (MP) treatment regimen has been combined with substances such as Velcade (bortezomib) and thalidomide for more effective results. In particular, clinical trials have shown that these new combination treatments produce greater responses in patients than the traditional MP treatment regimen. However, the presence of side effects, in particular clotting in the veins, also known as deep-vein thrombosis, and nerve damage in the limbs, also known as peripheral neuropathy, leaves room for improvement in these treatment options. Defibrotide, an anti-clotting compound, has been shown to sensitize myeloma cells to chemotherapy in in vitro studies when combined… Read the full story » | . |
LLS Increases Financial Support For Myeloma Patients – As of Feb 1, the Leukemia & Lymphoma Society (LLS) will provide multiple myeloma patients with up to $10,000 to cover insurance-related expenses such as co-payments and insurance premiums. The new limit is an increase from the previous limit of $5,000 and is retroactive for expenses beginning July 1, 2009. For more information or to apply, please see the LLS Co-Pay Assistance Web site.
Carfilzomib Phase 3 Clinical Trial Design Is Approved – Onyx Pharmaceuticals, Inc. announced that it has reached an agreement with the Food and Drug Administration on the design and analysis of a Phase 3 clinical trial evaluating carfilzomib in relapsed myeloma. The study follows up a Phase 1B trial that examined carfilzomib in combination with Revlimid (lenalidomide) and dexamethasone (Decadron) (see related Beacon news). The Phase 3 trial is expected to begin in early to mid 2010, and the Phase 1b/2 study of this combination regimen is still recruiting participants. For more information, please see the Onyx press release.
Cancer Vaccine Produces Positive Results In Multiple Myeloma Patient – Results from a study evaluating the effects of a high dose cancer vaccine in patients with multiple myeloma, myelodysplastic syndromes, and acute myeloid leukemia showed positive immune responses in several patients. The vaccine helps the immune system kill cancer cells by building up antibodies to a protein called RHAMM, which is associated with cancer progression. In one of the three myeloma patients, the vaccine led to a decrease of the patient’s free light chains, from 10.3 mg/L to 2.26 mg/L. Side effects were limited to mild redness and infection of the skin. For more information, please see the journal Haematologica (pdf).
A combination regimen of Velcade (bortezomib), Doxil (pegylated liposomal doxorubicin), and dexamethasone (Decadron), known as the VDD regimen, followed by Revlimid (lenalidomide) after autologous stem cell transplantation (ASCT) is an effective therapy for untreated multiple myeloma patients, according to a study recently published in the Journal of Clinical Oncology.
Velcade is a highly active therapeutic agent in multiple myeloma patients. It suppresses tumor growth by inhibiting the enzymes that break down critical proteins in cancerous cells. Although Velcade is approved as a single agent, previous studies have suggested that the Velcade and Doxil combination is…
Phil Brabbs, a software product manager and former kicker for the University of Michigan football team, was diagnosed with smoldering multiple myeloma the day after his 28th birthday. “At 28, looking at my son who was two, you think, ‘Will this kid ever remember me?’ It was really frightening,” he said.
“To get a cancer diagnosis when it seems like you’re doing everything right – you don’t smoke, you drink modestly, you exercise – it was quite shocking. But I don’t think it took more than a week or two for…
Panobinostat In Combination With Velcade Shows Potential For Relapsed Multiple Myeloma (ASH 2009) – Researchers presented results at the American Society of Hematology Meeting (ASH) from a Phase 1 clinical trial that show that oral panobinostat (LBH589) in combination with intravenous Velcade (bortezomib) has anti-myeloma effects. Researchers tested different doses of both panobinostat (10 mg to 30 mg) and Velcade (1.0 mg/m2 to 1.3 mg/m2). They found frequent blood-related adverse events, such as thrombocytopenia (low blood platelet count) and neutropenia (low white blood cell count). They concluded that dosing will be modified for future Phase 2/3 studies. For more information, please see abstract 3852 on the ASH Meeting Web site.
Afinitor Is Safe In Relapsed And Refractory Multiple Myeloma; Drug Will Move To Phase 2 Clinical Trials (ASH 2009) – Afinitor (everolimus) is safe in relapsed and refractory multiple myeloma, according to preliminary results from a Phase 1/2 clinical trial presented at the 2009 Meeting of the American Society of Hematology (ASH). Afinitor was given orally at 5 mg to 10 mg daily. Researchers observed only one case of thrombocytopenia (low platelet count). A sufficient amount of anti-myeloma activity was observed for this drug to continue to Phase 2 testing, which puts more emphasis on the efficacy of the drug. For more information, see abstract 3850 on the ASH Meeting Web site.
ACE-011 Increases Hemoglobin And Helps Build Bone In Multiple Myeloma Patients Receiving Chemotherapy (ASH 2009) – Preliminary results from a study presented at the 2009 Meeting of the American Society of Hematology (ASH) reveal that ACE-011 increases hemoglobin (an iron-rich protein in red blood cells) and bone formation, decreases bone pain, and has anti-tumor activity in multiple myeloma patients receiving chemotherapy. A low hemoglobin count indicates a low red blood cell count (anemia), which is a common complication in multiple myeloma, as are bone lesions, and bone pain. All participants were on a regimen of melphalan (Alkeran), prednisone, and thalidomide (Thalomid). For more information, see abstract 749 on the ASH Meeting Web site.
Researchers Demonstrate Feasibility And Safety Of Vaccine In Multiple Myeloma (ASH 2009) – Preliminary results from a Phase 1 clinical trial of a multiple myeloma vaccine, presented at the 2009 Meeting of the American Society of Hematology (ASH), indicate that using a vaccine in multiple myeloma is possible and that it is safe and tolerable. The study included 15 patients who had undergone peripheral blood progenitor cell transplantation – a treatment in which stem cells are collected from the bloodstream of a healthy donor and delivered to the myeloma patient after high-dose chemotherapy. The most frequent side effects were local skin reactions, typical of most vaccines. Further studies will evaluate the vaccine’s full potential. For more information, see abstract 1858 on the ASH Meeting Web site.
For more information about myeloma-related studies covered at ASH, please see the Myeloma Beacon coverage of the ASH 2009 Meeting.
The preliminary findings of a Phase 3 trial suggest that Revlimid (lenalidomide) improves the complete response rate in multiple myeloma patients who had undergone an autologous stem cell transplant (ASCT). Researchers presented the results of the trial at the American Society of Hematology’s annual meeting in December 2009.
In mid-January, Celgene further announced that, based on an interim analysis reviewed by an independent committee, the Phase 3 trial has met an additional primary endpoint. Patients on Revlimid showed better progression-free survival than patients on a placebo. Final results will be presented at…