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Showing 201 - 250FDA Grants Priority Review to Ixazomib for Patients With Relapsed/Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application for the investigational oral proteasome inhibitor ixazomib for the treatment of patients with relapsed or refractory multiple myeloma, Takeda Pharmaceuticals announced. The New Drug...
Pooled Analysis Shows Improved Outcomes With Continuous vs Fixed-Duration Therapy in Newly Diagnosed Multiple Myeloma
In a pooled analysis of trials assessing novel agent-based continuous therapy vs fixed duration of therapy reported in the Journal of Clinical Oncology, Palumbo et al found that continuous therapy prolonged progression-free survival, progression-free survival-2 (time to second progression or...
FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma
Bristol-Myers Squibb and AbbVie today announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the...
Study Identifies Gene Mutations Associated With Aggressive Multiple Myeloma
Using whole-exome sequencing on newly diagnosed patients with multiple myeloma, British researchers identified 15 genes that were significantly mutated in a subset of patients and mapped how these mutations related to long-term survival. They found 90% of patients with very aggressive disease who...
International Myeloma Working Group Defines Revised International Staging System for Multiple Myeloma
As reported in the Journal of Clinical Oncology by Palumbo et al, the International Myeloma Working Group recommends the use of a revised international staging system (R-ISS) for newly diagnosed multiple myeloma that incorporates chromosomal abnormalities detected by interphase fluorescent in situ...
Poor Survival in Patients With Multiple Myeloma Linked to Genetic Variation
As part of a multi-institutional effort, researchers with Huntsman Cancer Institute at the University of Utah have found that patients with multiple myeloma with a genetic variation in the gene FOPNL die, on average, 1 to 3 years sooner than patients without it. The finding was identified with...
FDA Approves Carfilzomib Combination for Patients With Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The approval was based on a demonstration of ...
T-cell Receptor Therapy Achieves Encouraging Clinical Responses in Multiple Myeloma
Results from a clinical trial investigating a new T-cell receptor therapy demonstrated a clinical response in 80% of patients with multiple myeloma who had advanced disease after undergoing autologous stem cell transplants. Researchers at Penn’s Abramson Cancer Center modified T cells to ...
Study Links Leisure Time Sitting to Higher Risk of Specific Cancers and Total Cancer Risk in Women
Spending more leisure time sitting was associated with a higher risk of total cancer risk in women, specifically heightened multiple myeloma, breast, and ovarian cancer risk, according to a new study by the American Cancer Society. The higher risk was present even after taking into account body...
Community-Based Trial Suggests No Benefit of Adding Thalidomide or Melphalan to Bortezomib-Based First-Line Treatment of Myeloma
In the U.S. community-based phase IIIB UPFRONT trial reported in the Journal of Clinical Oncology, Niesvizky et al found no benefit of adding thalidomide (Thalomid) or melphalan to first-line bortezomib (Velcade)-based treatment in transplant-ineligible myeloma patients. Study Details In the...
Daratumumab Expanded Access Program Open to Eligible U.S. Patients With Heavily Pretreated Multiple Myeloma
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible U.S. patients. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The multicenter, open-label...
Addition of Elotuzumab to Lenalidomide-Dexamethasone Improves Progression-Free Survival in Relapsed/Refractory Multiple Myeloma
In an interim analysis of the phase III ELOQUENT-2 trial reported in The New England Journal of Medicine, Lonial et al found that the addition of the investigational agent elotuzumab to lenalidomide (Revlimid)-dexamethasone significantly increased progression-free survival in patients with relapsed ...
ASCO 2015: Phase III Study Confirms Benefits of Lenalidomide Maintenance Therapy for Patients With Multiple Myeloma
A large, cooperative group study directed by the Alliance for Clinical Trials in Oncology has confirmed previous evidence that the drug lenalidomide (Revlimid) delays time to disease progression for patients with multiple myeloma and is an important treatment option for patients with this rare but...
ASCO 2015: First-in-Class Targeted Drug Daratumumab Is Effective as Single Agent in Heavily Treated Multiple Myeloma
“Daratumumab monotherapy produced unprecedented overall responses that deepened over time” in a phase II trial among patients with heavily treated multiple myeloma, study author Saad Zafar Usmani, MD, reported at a press conference at the 2015 ASCO Annual Meeting. Dr. Usmani, a...
Study Links Paternal Age to Child’s Risk of Developing Blood and Immune System Cancer in Adulthood
A new study links a father's age at birth to the risk that his child will develop blood and immune system cancers as an adult, particularly for only children. The study, published by Teras et al in the American Journal of Epidemiology, found no association between having an older mother and these...
ASCO 2015: Adding Elotuzumab Significantly Reduces Risk of Progression for Relapsed Multiple Myeloma
Interim results of a phase III trial suggest an innovative immune-based therapy may offer a new option for patients with relapsed multiple myeloma. The new monoclonal antibody elotuzumab, added to standard lenalidomide (Revlimid) and dexamethasone therapy, extended the duration of remissions by...
Panobinostat and Carfilzomib Combination Appears Safe and Effective in Relapsed/Refractory Multiple Myeloma
In patients with relapsed/refractory multiple myeloma, the combination of panobinostat (Farydak) and carfilzomib (Kyprolis) appears to be safe and effective, according to a phase I/II study by Berdeja et al in Haematologica. Further evaluation of this combination treatment is warranted to establish ...
FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the...
FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) today approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is...
FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
‘Frailty Profile’ Predicts Survival and Toxicities Among Elderly Patients With Multiple Myeloma
A frailty score predicts mortality and the risk of toxicity in elderly patients with multiple myeloma and can be used to determine more suitable therapies for these patients, the International Myeloma Working Group reported in Blood. “Chronologic age, performance status, and physician's...
Supplemental New Drug Application Submitted for Carfilzomib for Relapsed Multiple Myeloma
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at...
ASH 2014: Ibrutinib Demonstrates Clinical Activity in Relapsed or Refractory Multiple Myeloma
According to new data reported at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, ibrutinib (Imbruvica) demonstrated antitumor activity both as a single agent and in combination with dexamethasone in heavily pretreated patients with relapsed or relapsed/refractory...
ASH 2014: Strong Showing for Anti-CD38 Monoclonal Antibodies in Myeloma
An investigational new class of drugs, the anti-CD38 monoclonal antibodies, could be the next blockbuster agents in multiple myeloma, experts in this malignancy predicted at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. Anti-CD38 antibodies target multiple myeloma...
ASH 2014: Carfilzomib-Based Triplet Yields ‘Unprecedented’ Duration of Remission in Relapsed Myeloma
The phase III global ASPIRE trial documented an “unprecedented” duration of remission in relapsed multiple myeloma patients receiving carfilzomib (Kyprolis) plus a standard-of-care doublet, according to A. Keith Stewart, MD, of the Mayo Clinic in Scottsdale, Arizona, who presented the...
Updated GEM2005 Trial Confirms Benefit of Melphalan/Bortezomib Combination in Elderly Multiple Myeloma Patients
Melphalan in combination with bortezomib (Velcade) should be maintained as one of the standards of care for the treatment of elderly patients with multiple myeloma, concluded Spanish trialists reporting updated results from the GEM2005 study comparing bortezomib/melphalan/prednisone with...
Subclinical Peripheral Neuropathy Is Common in Treatment-Naive Multiple Myeloma Patients, Correlates With Decreased Fingertip Innervation Density
In a study reported in the Journal of Clinical Oncology, Kosturakis et al found that the majority of patients with multiple myeloma had subclinical peripheral neuropathy prior to chemotherapy and that deficits corresponded with decreased fingertip innervation density. Study Details In the study,...
Continuous Lenalidomide/Dexamethasone Improves Progression-Free Survival in Transplant-Ineligible Patients With Myeloma
In the phase III FIRST trial reported in The New England Journal of Medicine, Benboubker et al found that continuous lenalidomide (Revlimid) plus dexamethasone significantly improved progression-free survival vs melphalan/prednisone/thalidomide (Thalomid) in transplant-ineligible myeloma patients....
Clinical Trials Investigate Treatment Options for Precursor Diseases to Multiple Myeloma
The availability of newer agents that have transformed treatment outcomes in multiple myeloma has naturally led to interest in studying these drugs earlier in precursor states, such as monoclonal gammopathy of undetermined significance and smoldering myeloma. Recent evidence suggests that this may...
Adding Pan-Deacetylase Inhibitor Panobinostat to Bortezomib and Dexamethasone Improves Progression-Free Survival in Relapsed Myeloma
In the phase III PANORAMA1 trial reported in The Lancet Oncology, San-Miguel and colleagues found that adding the pan-deacetylase inhibitor panobinostat to bortezomib (Velcade) and dexamethasone improved progression-free survival in patients with relapsed or relapsed and refractory multiple...
Improved Outcomes in Myeloma With High-Dose Melphalan Plus Autologous Transplant and Lenalidomide Maintenance
In a phase III trial reported in The New England Journal of Medicine, Palumbo et al found that consolidation therapy with high-dose melphalan plus autologous stem cell transplantation improved progression-free survival and overall survival compared with melphalan/prednisone/lenalidomide (Revlimid)...
FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma
The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes...
Lenalidomide, Bortezomib, and Dexamethasone Induction and Consolidation Effective in Multiple Myeloma in French Phase II Trial
In a phase II Intergroupe Francophone du Myélome (IFM) trial reported in the Journal of Clinical Oncology by Roussel et al, induction and consolidation treatment with RVD (lenalidomide [Revlimid], bortezomib [Velcade], and dexamethasone) followed by lenalidomide maintenance was associated...
High-Dose Melphalan Plus Autologous Stem Cell Transplantation as Consolidation Shows Benefit in Relapsed Multiple Myeloma After Previous Transplant
In a UK phase III trial (NCRI Myeloma X Relapse [Intensive] Trial) reported in The Lancet Oncology, Cook et al found that high-dose melphalan plus salvage autologous stem cell transplantation significantly prolonged time to progression vs cyclophosphamide in patients with relapsed multiple myeloma...
Scientists Engineer Nanoparticles to Prevent Bone Cancer, Strengthen Bones
A research collaboration between Dana-Farber Cancer Institute and Brigham and Women’s Hospital has utilized nanomedicine technologies to develop a drug-delivery system that can precisely target and attack cancer cells in the bone, as well as increase bone strength and volume to prevent...
Combined Index Predicts Early Multiple Myeloma Progression-Related Death in Patients Receiving Front-Line Autologous Stem Cell Transplantation
In a European study reported in the Journal of Clinical Oncology, Moreau et al developed and validated a combined index for prognosis in patients with multiple myeloma treated with front-line autologous stem cell transplantation. The index, consisting of high lactate dehydrogenase (LDH) level,...
Immunotherapy May Be Effective in the Treatment of Multiple Myeloma
A new study by researchers at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC–James) provides evidence that genetically modifying immune cells might effectively treat multiple myeloma. The findings by ...
African Americans Have Higher Prevalence of Multiple Myeloma Precursor Than Whites and Hispanics
A large population-based study by Landgren et al has found that African Americans are more likely to have a higher prevalence of monoclonal gammopathy of undetermined significance (MGUS), a precursor to the development of multiple myeloma, compared with whites or Hispanics. The study is published...
Lenalidomide, Particularly When Combined With Oral Melphalan, Increases Risk of Second Primary Hematologic Malignancy in Myeloma Therapy
Lenalidomide (Revlimid) has been associated with risk for second primary malignancies in patients with myeloma. In a meta-analysis of individual patient data reported in The Lancet Oncology, Palumbo et al found that lenalidomide was associated with a significantly increased risk of second primary...
Improved Survival With Four-Drug Induction Regimen Followed by Maintenance in Initial Treatment of Transplant-Ineligible Multiple Myeloma
In an updated analysis of an Italian phase III trial reported in the Journal of Clinical Oncology, Palumbo et al found that induction with bortezomib (Velcade), melphalan, prednisone, and thalidomide (Thalomid) followed by bortezomib plus thalidomide maintenance (VMPT-VT) significantly improved...
Multiple Myeloma Study Shows Widespread Genetic Heterogeneity
A detailed study of tissue samples from more than 200 patients with multiple myeloma has found that an individual patient’s tumor can harbor populations of cancer cells equipped with different mutations. The result could have therapeutic ramifications for future patients, according to study...
Updated Myeloma Trial Shows Lenalidomide Maintenance Post-Transplant Improves Progression-Free But Not Overall Survival
A new analysis of the multiple myeloma IFM 2005-02 trial showed that lenalidomide (Revlimid) maintenance prolongs progression-free survival after stem cell transplantation, but does not improve overall survival. This is possibly attributed to the shorter survival time after first disease...
Continuous Lenalidomide/Low-Dose Dexamethasone Improves Survival vs Standard Treatment in Older Patients With Newly Diagnosed Myeloma
First-line treatment of newly diagnosed multiple myeloma using continuous treatment with the doublet of lenalidomide (Revlimid) and low-dose dexamethasone was superior to standard triplet treatment with melphalan, prednisone, and thalidomide (Thalomid) for 72 weeks, according to initial results of...
Three-Drug Regimen Produces High Response Rate in Relapsed/Refractory Multiple Myeloma
A phase II trial to evaluate the combination of bendamustine (Treanda) with bortezomib (Velcade) and dexamethasone in patients with relapsed/refractory multiple myeloma “showed a remarkable response rate of 60.9%, and, when minor responses were included in 75.9% of patients,”...
Multiple Myeloma Defined by Light Chain Amyloidosis With Plasma Cell or CRAB Criteria
In a study reported in Journal of Clinical Oncology, Taxiarchis V. Kourelis, MD, and colleagues from the Mayo Clinic attempted to define a threshold of bone marrow plasma cell number that could serve to define light chain amyloidosis as light chain amyloidosis with multiple myeloma. They found that ...
Addition of Vorinostat to Bortezomib Results in Small Progression-Free Survival Advantage in Previously-Treated Multiple Myeloma
In a phase III study (VANTAGE 088 trial) reported in The Lancet Oncology, Meletios Dimopolous, MD, of the University of Athens, and colleagues assessed the addition of the oral HDAC inhibitor vorinostat (Zolinza) to bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma. The...
Myeloma Foundation Launches Open Access Gateways to Accelerate Drug Development
The Multiple Myeloma Research Foundation (MMRF) has announced two open access gateways, the MMRF Researcher Gateway, which will upload genomic data as it becomes available and make it accessible to all researchers, and the MMRF CoMMunity Gateway, which will aggregate subtypes of myeloma patients...
Pomalidomide Produces ‘Impressive Results’ in Patients With Multiple Myeloma Who Are Refractory to Bortezomib and Lenalidomide
The second-generation immunomodulatory drug pomalidomide (Pomalyst) “has shown impressive results in patients with multiple myeloma who are refractory to lenalidomide and bortezomib,” according to a review of clinical data leading to the drug’s approval by the U.S. Food and Drug...
Researchers Uncover Root Cause of Multiple Myeloma Relapse
Researchers have discovered why multiple myeloma frequently recurs after an initially effective treatment that can keep the disease at bay for up to several years. The study, published in Cancer Cell, was a collaboration between researchers at Princess Margaret Hospital in Toronto, Mayo Clinic in...
Pomalidomide Plus Low-Dose Dexamethasone Improves Survival vs High-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma
Pomalidomide (Pomalyst) alone has shown limited efficacy in relapsed multiple myeloma, but synergistic effects have been noted when it is combined with dexamethasone. In a phase III trial (MM-003) reported in The Lancet Oncology, Jesus San Miguel, MD, of Universidad de Salamanca, and colleagues...
