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Showing 901 - 950FDA 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...
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...
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 ...
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...
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...
Fine-Tuning Treatment in Myeloma and Leukemia
It is a difficult task to include every notable presentation from the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. In addition to our more comprehensive coverage of the news from that meeting over the past several issues, below are summaries of additional key...
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...
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...
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...
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...
ASCO Names CAR T-Cell Immunotherapy Its Clinical Advance of the Year
This past January, ASCO published Clinical Cancer Advances 2018,1 its 13th annual report on the progress being made against cancer. The report names chimeric antigen receptor (CAR) T-cell immunotherapy as ASCO’s Advance of the Year. In 2017, the U.S. Food and Drug Administration (FDA) approved two ...
The WHO Classification of Tumors of Hematopoietic and Lymphoid Tissues
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 Medeiros explore the recently updated World Health Organization (WHO) classification of hematopoietic and lymphoid tissue...
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,...
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...
Acupuncture for the Management of Chemotherapy-Induced Peripheral Neuropathy
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Ting Bao, MD, DABMA, MS, reviews the current data on the use of acupuncture...
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...
Cognitive Decline Prevalent Among Elderly Patients With Hematologic Cancers
A sizable percentage of elderly patients with blood-related cancers such as leukemia and multiple myeloma are apt to show signs of diminished cognitive functioning—a decline that may impact their survival—a new study by investigators at Dana-Farber Cancer Institute and Brigham and...
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...
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)...
Madhav V. Dhodapkar, MBBS, Named Director of New Center for Cancer Immunology at Winship Cancer Institute
MADHAV V. DHODAPKAR, MBBS, a world-renowned expert in cancer immunology and translational immunotherapy, joined Winship Cancer Institute of Emory University as Director of the new Winship Center for Cancer Immunology. He has been appointed as the Anise McDaniel Brock Chair, Georgia Research...
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 ...
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 ...
NCCN Summit Explores Survivorship Issues for Patients and Clinicians
When Yelak Biru was diagnosed with multiple myeloma in 1995, he and his physicians had one main posttreatment goal: to detect and treat any relapse early and to prolong survival as long as possible with the limited drugs available. Then, in the early 2000s, came newer treatments. Myeloma survival...
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. ...
ASCO Names Adoptive Cell Immunotherapy as Cancer Advance of the Year
In Clinical Cancer Advances 2018: ASCO’s Annual Report on Progress Against Cancer, which highlights the most impactful cancer research progress and the importance of federally funded research, ASCO recognized a type of adoptive cell immunotherapy—chimeric antigen receptor (CAR) T-cell therapy—as...
Daratumumab Shows Efficacy in Amyloid Light-Chain Amyloidosis
DARATUMUMAB (DARZALEX) may be an effective treatment for systemic amyloid light-chain (AL) amyloidosis, according to phase II studies reported at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition.1,2 While the cohorts were small and the arms uncontrolled, the findings...
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...
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...
Bone-Modifying Agents in Metastatic Breast Cancer: Time to De-escalate Dosing Intervals
AS REVIEWED in this issue of The ASCO Post, ASCO and Cancer Care Ontario (CCO) have issued an updated guideline on the role of bone-modifying agents in metastatic breast cancer.1 The updated guideline supports a change in clinical practice for our patients with breast cancer and bone metastasis....
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...
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...
CAR T-Cell Immunotherapy Named Advance of the Year in ASCO’s Clinical Cancer Advances 2018
A new and unique new way to treat cancer—chimeric antigen receptor (CAR) T-cell therapy—is poised to transform the outlook for children and adults with certain otherwise incurable cancers. ASCO named this type of adoptive-cell immunotherapy the Advance of the Year in its annual...
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...
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...
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...
Expert Point of View: Andrzej Jakubowiak, MD, PhD
Andrzej Jakubowiak, MD, PhD, Director of the Multiple Myeloma Program at the University of Chicago Medical Center, commented on the study for The ASCO Post. “Overall, I was impressed with these results. They make an important contribution to the field. This is an advance in the right direction,”...
Carfilzomib-Based Treatment and Transplant in Smoldering Myeloma
Can aggressive treatment of high-risk smoldering multiple myeloma patients prevent disease worsening? A carfilzomib (Kyprolis)-based regimen and autologous stem cell transplant (ASCT) plus maintenance produced encouraging outcomes in the phase II GEM-CESAR study by the Spanish Myeloma Group. The...
Study Findings on Novel Therapies for Hematologic Malignancies
Here is an update on five different studies featured at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics center on possible newer treatment regimens in both Hodgkin and Burkitt lymphomas, relapsed or refractory chronic lymphocytic leukemia, and newly...
Expert Point of View: Laurie Sehn, MD and Kenneth C. Anderson, MD
“We don’t think a lot about cutaneous T-cell lymphoma because it is one of the rare forms of lymphoma that we treat, but it is an extremely debilitating type of lymphoma,” said press briefing moderator Laurie Sehn, MD, Chair of the Lymphoma Tumour Group of the British Columbia Cancer Agency in...
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...
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...
Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...
FDA Helps Streamline Approval Process for Supplemental Drug Indications
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...
ASCO Expands TAPUR Study Enrollment After Promising Initial Treatment Outcomes
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study has expanded four cohorts for enrollment of additional participants and continues to grow, with more than 500 participants and 16 therapies now available. The TAPUR Study is designed to identify signals of activity of...
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...
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...
ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...
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...
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...
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...
