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multiple myeloma

FDA Grants Orphan Drug Designation to Galinpepimut-S for Treatment of Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to galinpepimut-S for the treatment of multiple myeloma. The drug is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor...

Multiple Myeloma
Immunotherapy

FDA Approves Daratumumab/VMP Combination for Newly Diagnosed Multiple Myeloma

On May 7, the U.S. Food and Drug Administration(FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for...

multiple myeloma
immunotherapy

FDA Approves Daratumumab in Combination With VMP for Newly Diagnosed Patients With Multiple Myeloma Who Are Transplant-Ineligible

On May 7, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are...

Hematologic Malignancies
Multiple Myeloma

Role of Bone-Modifying Agents in Multiple Myeloma

As reported in the Journal of Clinical Oncology by Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute, and colleagues, ASCO has issued a clinical practice guideline update on the role of bone-modifying agents in multiple myeloma.1 The update was performed by an expert panel systematic...

Hematologic Malignancies
Multiple Myeloma

Multiple Myeloma Research Foundation Awards $7M to Advance Immunotherapy Research

The Multiple Myeloma Research Foundation announced that, as part of its $15M Immunotherapy Initiative, it has awarded $7 million to fund three research programs led by myeloma researchers. The Immunotherapy Initiative, through the formation of highly collaborative, multidisciplinary Immune Networks ...

multiple myeloma

MGUS and Multiple Myeloma in 9/11 Firefighters

A study by Landgren et al in JAMA Oncology has found that New York City firefighters exposed to the 9/11 World Trade Center (WTC) disaster site face an increased risk for developing monoclonal gammopathy of undetermined significance (MGUS), a myeloma precursor disease. The study was conducted...

Multiple Myeloma

Updated International Myeloma Working Group Criteria: Diagnostic Challenges

The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib and Landgren review the underlying data that shaped the updated International Myeloma Working Group (IMWG) diagnostic criteria for...

multiple myeloma

Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma

On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.  The FDA’s...

Hematologic Malignancies
Multiple Myeloma

Cardiovascular Toxicity and Carfilzomib Treatment in Multiple Myeloma

The proteasome inhibitor carfilzomib (Kyprolis) has taken on an increasing role in the treatment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the therapy may come with the risk of cardiovascular problems in a higher-than-expected...

Multiple Myeloma

EXPERT POINT OF VIEW: Kenneth C. Anderson, MD, and S. Vincent Rajkumar, MD

AT A PREMEETING webinar, American Society of Hematology then President Kenneth C. Anderson, MD, Director of the Lebow Institute for Myeloma Therapeutics and Jerome Lipper Myeloma Center at Dana-Farber Cancer Institute, Boston, commented: “This study demonstrates this new treatment has good...

Multiple Myeloma
Immunotherapy

Unique CAR T-Cell Construct Studied in Multiple Myeloma

CD19-DIRECTED chimeric antigen receptor (CAR) T-cell therapy has been approved by the U.S. Food and Drug Administration for the treatment of leukemia (tisagenlecleucel [Kymriah]) and lymphoma (axicabtagene ciloleucel [Yescarta]), but another type of CAR T-cell therapy is generating interest as a...

Multiple Myeloma

EXPERT POINT OF VIEW: Andrzej Jakubowiak, MD, PhD

INTERVIEWED BY The ASCO Post, Andrzej Jakubowiak, MD, PhD, Director of the Multiple Myeloma Program at the University of Chicago Medical Center, commented on the “controversial findings” of EMN02/HO95. “This European study has opened the gate toward showing the benefit of a second transplant,...

Multiple Myeloma

European Study Shows Double Transplant Improves Survival in Myeloma

FOR NEWLY DIAGNOSED patients with multiple myeloma considered to be at high risk of disease progression, double autologous stem cell transplantation (ASCT) significantly prolongs progression-free and overall survival, vs single transplant, according to the phase III EMN02/HO95 study. The findings...

multiple myeloma
symptom management

Analysis of Carfilzomib-Related Cardiotoxicity

In a systematic review and meta-analysis reported in Leukemia & Lymphoma, Shah et al identified the risk of cardiotoxicity among patients, most with multiple myeloma, receiving carfilzomib (Kyprolis) in clinical trials. Study Details The study included data from 4,164 patients who received...

multiple myeloma

Denosumab vs Zoledronic Acid in Newly Diagnosed Multiple Myeloma With Bone Disease

In a phase III trial reported in The Lancet Oncology, Raje et al found that denosumab was noninferior to zoledronic acid in preventing skeletal-related events (SREs) in newly diagnosed multiple myeloma patients with bone disease. Study Details In the double-blind trial, 1,718 patients with at...

Multiple Myeloma

Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma

As reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, Alexandra Hospital, and colleagues in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis)...

Multiple Myeloma

Results From Phase III ARROW Study of Once-Weekly Carfilzomib in Relapsed or Refractory Multiple Myeloma

TOPLINE RESULTS of the phase III ARROW trial (ClinicalTrials.gov identifier NCT02412878) were recently announced by Amgen. The study showed carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed patients with relapsed or refractory multiple myeloma to live 3.6 months ...

multiple myeloma
immunotherapy

Pomalidomide and Low-Dose Dexamethasone in Patients With Multiple Myeloma and Renal Impairment

In a European phase II trial reported in the Journal of Clinical Oncology, Dimopoulos et al found that pomalidomide (Pomalyst) plus low-dose dexamethasone produced responses in patients with relapsed or refractory multiple myeloma and renal impairment. Study Details In the study, 81 patients with ...

multiple myeloma

Selective Inhibition of Nuclear Export in Heavily Pretreated Relapsed or Refractory Multiple Myeloma

In a phase II trial reported in the Journal of Clinical Oncology, Vogl et al found that the investigational oral selective exportin 1 (XPO1) inhibitor selinexor combined with dexamethasone produced responses in patients with heavily pretreated relapsed or refractory multiple myeloma. ...

Multiple Myeloma

EXPERT POINT OF VIEW: Ken Shain, MD

KEN SHAIN, MD, Assistant Member of the Department of Malignant Hematology and Tumor Biology, Moffitt Cancer Center in Tampa, Florida, and Scientific Director of the Moffitt Myeloma Working Group, moderated the session where the study was presented and offered comments to The ASCO Post. “Professor...

Multiple Myeloma

For Patients Treated for Myeloma, Antibiotic Prophylaxis May Reduce Infections and Deaths

IN PATIENTS undergoing treatment of multiple myeloma, the prophylactic use of levofloxacin significantly reduced febrile episodes and deaths, without increasing healthcare-associated infections or carriage of key nosocomial pathogens, in a large multicenter study from the United Kingdom.1 The...

Hematologic Malignancies
Multiple Myeloma
Immunotherapy

Daratumumab in Previously Treated Multiple Myeloma

  On June 16, 2017, daratumumab -(Darzalex) was approved for use in combination with pomalidomide (Pomalyst) and dexamethasone for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.1,2 Supporting...

multiple myeloma
immunotherapy

ASPIRE Trial: Final Overall Survival Results in Relapsed or Refractory Multiple Myeloma

The final overall survival results of the phase III ASPIRE trial indicate significant improvement with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) vs lenalidomide plus dexamethasone (Rd) in patients who had received one to three prior lines of therapy for multiple...

multiple myeloma

Role of Bone-Modifying Agents in Multiple Myeloma: ASCO Clinical Practice Guideline Update

As reported in the Journal of Clinical Oncology by Kenneth Anderson, MD, of Dana-Farber Cancer Institute, and colleagues, ASCO has issued a clinical practice guideline update on the role of bone-modifying agents in multiple myeloma. The update was informed by an expert panel systematic literature...

multiple myeloma

Cardiovascular Adverse Events and Multiple Myeloma Treatment

In a systematic review and meta-analysis reported in JAMA Oncology, Waxman et al found that any-grade and grade ≥ 3 cardiovascular adverse events occurred in 18.1% and 8.2% of patients receiving carfilzomib (Kyprolis) for multiple myeloma in clinical trials. Study Details The study involved...

multiple myeloma
immunotherapy

FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting

On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...

multiple myeloma

FDA Approves Denosumab for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma

Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for denosumab (Xgeva) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients...

multiple myeloma

Treatment With Carfilzomib May Lead to Cardiovascular Toxicity in Patients With Multiple Myeloma

The proteasome inhibitor carfilzomib (Kyprolis) has taken on an increasing role in the treatment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the therapy may come with the risk of cardiovascular problems in a higher than expected...

Multiple Myeloma

Expert Point of View: Keith Stewart, MB, ChB

COMMENTING ON the ALCYONE trial for The ASCO Post, Keith Stewart, MB, ChB, the Carlson and Nelson Endowed Director of the Center for Individualized Medicine at the Mayo Clinic, Rochester, Minnesota, said, “Daratumumab added to a combination of drugs that we don’t use much anymore in the United...

Multiple Myeloma

Daratumumab Improves Progression-Free Survival in Front-Line Myeloma Setting

FOR NEWLY DIAGNOSED multiple myeloma patients not eligible for transplant, the addition of the anti-CD38 monoclonal antibody daratumumab (Darzalex) to subcutaneous bortezomib (Velcade), melphalan, and prednisone (VMP) reduced the risk of disease progression or death by 50%, the phase III ALCYONE...

multiple myeloma

ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma

The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials

In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...

multiple myeloma

Maria-Victoria Mateos, MD, PhD, on Multiple Myeloma: Results From the ALCYONE Trial

Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, discusses phase III study findings on daratumumab plus bortezomib, melphalan, and prednisone vs bortezomib, melphalan, and prednisone in patients ineligible for transplant who have been newly diagnosed with multiple myeloma (Abstract LBA-4).

multiple myeloma

ASH 2017: Clinical Activity Seen With Anti-BCMA CAR T-Cell Therapy in Heavily Pretreated Multiple Myeloma

A one-time infusion of an investigational chimeric antigen receptor (CAR) T-cell therapy that targets a protein found on most multiple myeloma cells elicited an 86% overall response rate in 21 patients whose disease had come back or had not responded after a median of seven prior treatments,...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

Watch for More From ASH 2017

Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...

Hematologic Malignancies
Lymphoma
Multiple Myeloma

CAR T-Cell Therapy Makes Further Inroads in Lymphoma and Myeloma

With the recent U.S. Food and Drug Administration (FDA) approvals of two chimeric antigen receptor (CAR) T-cell products, this novel approach seems to be moving into the mainstream. The approvals were tisagenlecleucel (also known as CTL019; Kymriah) for the treatment of pediatric B-cell acute...

Hematologic Malignancies
Multiple Myeloma

Evidence-Based Support for Triplet Therapies in Multiple Myeloma

Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...

multiple myeloma

Tandem Autologous/Allogeneic HCT With Maintenance Therapy in High-Risk Myeloma

In a phase II study reported in Blood Advances, Green et al found that tandem autologous/allogeneic hematopoietic cell transplantation (HCT) followed by bortezomib (Velcade) maintenance produced good results in patients with newly diagnosed high-risk multiple myeloma. Poorer outcomes were observed...

Genomics/Genetics
Solid Tumors
Lymphoma
Multiple Myeloma

Update on NCI-MATCH Precision Medicine Trial

THE NATIONAL CANCER INSTITUTE (NCI) Molecular Analysis for Therapy Choice (MATCH) clinical trial has achieved the goal of screening nearly 6,000 patients in just under 2 years, according to data presented at the 2017 American Association for Cancer Research–NCI–European Organisation for Research...

Multiple Myeloma

Management of Newly Diagnosed Multiple Myeloma in Transplant-Eligible Patients

The treatment paradigm for multiple myeloma has changed dramatically in the past decade with the availability of several efficacious agents in various drug classes. At the National Comprehensive Cancer Network® (NCCN®) 13th Annual Congress: Hematologic Malignancies™, Shaji K. Kumar, MD, Professor...

Multiple Myeloma

ENDEAVOR Trial Endeavors to Make Case for Carfilzomib: Despite Survival Advantage, Should We Be Surprised?

LOCATION! LOCATION! LOCATION! That’s what home buyers are frequently cautioned about before purchasing a property. For trialists, and more importantly, practicing oncologists, a study’s design, akin to a property’s location, must be taken into account prior to buying into the results and changing ...

multiple myeloma

Results From Phase III ARROW Study of Once-Weekly Carfilzomib in Relapsed/Refractory Multiple Myeloma

On October 23, topline results of the phase III ARROW trial were announced, showing carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than...

Multiple Myeloma

Carfilzomib May Be a Strong Candidate for Salvage Therapy in Relapsed/Refractory Multiple Myeloma—but Questions Remain

WITH THE INCLUSION of proteasome inhibitors and immunomodulatory agents first into salvage and then as components of first-line, consolidation, and maintenance regimens, response rates, depth of response, and median progression-free and overall survival have all improved for patients suffering...

Multiple Myeloma

Carfilzomib Improves Overall Survival vs Bortezomib in Relapsed/Refractory Multiple Myeloma

AT A PRESPECIFIED interim analysis, the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, as reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian...

multiple myeloma

NCCN Guidelines to Include Categories of Preference

The National Comprehensive Cancer Network® (NCCN®) has instituted Categories of Preference for recommendations within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Initially, Categories of Preference will be published for drugs and biologics recommended within...

Hematologic Malignancies
Multiple Myeloma

Testing Alpha-Emitting Radiolabeled Immunotherapy to Treat—and Potentially Cure—Multiple Myeloma

Despite a flurry of treatment advances in multiple myeloma over the past decade that have increased overall survival from just 2 to 3 years in the 1990s to between 5 and 7 years today—with some data suggesting an extended life expectancy of between 7 and 10 years1—the cancer remains stubbornly...

Solid Tumors
Hematologic Malignancies
Breast Cancer
Lung Cancer
Prostate Cancer
Multiple Myeloma
Kidney Cancer

Journal of Clinical Oncology Literature Update

Staying up-to-date in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology. The topics range from therapy for stage IV non–small cell lung cancer...

Hematologic Malignancies
Multiple Myeloma

Multiple Myeloma: Researchers Are Digging Deeper Than Ever

Researchers are tackling multiple myeloma from many angles, and the result could be a flood of novel approaches soon within the oncologist’s reach, according to Kenneth C. Anderson, MD. At the 2017 Debates and Didactics in Hematology and Oncology Conference at Sea Island, Georgia, Dr. Anderson...

multiple myeloma

Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma

As reported by Dimopoulos et al in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma. Carfilzomib was...

multiple myeloma

FDA Statement Regarding Safety Concerns Related to Investigational Use of Pembrolizumab in Multiple Myeloma

On August 31, U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research Director Janet Woodcock, MD, issued the following statement: “Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening...

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