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multiple myeloma
immunotherapy

FDA Approves Daratumumab Split-Dosing Regimen

The U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for daratumumab (Darzalex), a CD38-directed antibody, providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. The approval is based on...

Immunotherapy
Multiple Myeloma

Multiple Myeloma Pipeline Filled With CAR T-Cell Therapies

The burgeoning pipeline of chimeric antigen receptor (CAR) T-cell therapies targeting B-cell maturation antigen (BCMA) in multiple myeloma was on full display at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. A bispecific antibody also made its debut in this busy...

multiple myeloma

Trial of Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma

In a phase III trial reported in the Journal of Clinical Oncology, Stadtmauer and colleagues found that second autologous hematopoietic cell transplantation (AHCT) or RVD (lenalidomide, bortezomib, dexamethasone) consolidation as post-AHCT interventions did not improve outcomes vs single...

Hematologic Malignancies
Multiple Myeloma
Immunotherapy

Novel Therapeutics for Relapsed or Refractory Multiple Myeloma, Part 2

Here is an update on several different studies focusing on novel treatments for patients with relapsed or refractory multiple myeloma presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. The featured therapeutics include the oral agent selinexor in...

Hematologic Malignancies
Multiple Myeloma

Novel Treatments in Newly Diagnosed Multiple Myeloma, Part 1

Here is an update on several different studies focusing on novel treatments for patients with newly diagnosed multiple myeloma presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. Featured therapeutics include daratumumab plus lenalidomide and dexamethasone, ...

multiple myeloma

Lenalidomide Maintenance vs Observation in Newly Diagnosed Multiple Myeloma

In a UK phase III trial (Myeloma XI) reported in The Lancet Oncology, Jackson et al found that lenalidomide maintenance was associated with improved progression-free survival but not overall survival among patients with newly diagnosed multiple myeloma with at least minimal response to induction...

Multiple Myeloma

I Welcome Being the Face of Multiple Myeloma

Thirteen years ago, at age 34, I was healthy and enjoying life. I went to the gym almost daily, and when I wasn’t at the gym, I was shooting hoops with my friends. During a gym workout while on a family vacation, I suddenly felt excruciating pain in my left shoulder and thought I must have strained ...

Hematologic Malignancies
Multiple Myeloma
Immunotherapy

Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma

In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...

breast cancer
solid tumors
leukemia
lung cancer
lymphoma
multiple myeloma
issues in oncology
immunotherapy

FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling

The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...

multiple myeloma

ASH 2018: MAIA Trial: Does Adding Daratumumab Improve Outcomes in Patients With Newly Diagnosed Multiple Myeloma Ineligible for Stem Cell Transplant?

Interim results from a large international phase III clinical trial show that adding the immunotherapy daratumumab (Darzalex) to standard therapy significantly extended progression-free survival (PFS) in newly diagnosed patients with multiple myeloma who were ineligible for a stem cell transplant....

multiple myeloma

Paul Richardson, MD, on Multiple Myeloma: Results From the OP-106 Horizon Trial

Paul Richardson, MD, of Dana-Farber Cancer Institute, discusses updated results and the first report on progression-free survival for melflufen therapy administered to people with multiple myeloma that is refractory to daratumumab and/or pomalidomide (Abstract 600).

multiple myeloma

Francesca M. Gay, MD, on Multiple Myeloma: Results From the Forte Trial

Francesca M. Gay, MD, of GIMEMA, European Myeloma Network, discusses study findings on the use of carfilzomib in induction combination regimens with autologous transplantation, and consolidation regimens in newly diagnosed multiple myeloma (Abstract 121).

multiple myeloma

ELOQUENT-3: Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Multiple Myeloma

As reported in The New England Journal of Medicine by Dimopoulos et al, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and dexamethasone significantly prolonged progression-free survival in patients with relapsed and/or refractory...

Multiple Myeloma

FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

ON NOVEMBER 6, 2018, following Priority Review, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at...

multiple myeloma

FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies,...

multiple myeloma

FDA Accepts New Drug Application, Grants Priority Review to Selinexor for Pentarefractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has accepted a new drug application seeking accelerated approval for selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with pentarefractory multiple myeloma. The FDA...

Hematologic Malignancies
Multiple Myeloma

Emerging Options and Sequencing Therapy in Relapsed Multiple Myeloma

Advances in the treatment of multiple myeloma have led to longer progression-free survival, but the majority of patients will still relapse despite newer treatments. A number of new drugs and combinations are under study in the hope of improving outcomes. “Multiple myeloma is a complex disease...

leukemia
multiple myeloma

FDA Authorizes First Next-Generation Sequencing–Based Test to Detect Minimal Residual Disease in B-Cell ALL or Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently permitted marketing of the ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma. “At the FDA, we’re continuing to...

multiple myeloma

FDA Approves Once-Weekly Carfilzomib in Combination With Dexamethasone for Relapsed or Refractory Multiple Myeloma

Today, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) to expand the prescribing information for carfilzomib (Kyprolis) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or...

multiple myeloma

Shaji K. Kumar, MD, on Multiple Myeloma: Treatment Update

Shaji K. Kumar, MD, of the Mayo Clinic Cancer Center, discusses emerging therapeutic options for relapsed multiple myeloma and how best to sequence treatments.

multiple myeloma

Natalie S. Callander, MD, on Newly Diagnosed Multiple Myeloma: Expert Perspective

Natalie S. Callander, MD, of the University of Wisconsin Carbone Cancer Center, discusses key patient and clinical factors that influence first-line treatment choices, as well as the efficacy and tolerability of multiple myeloma therapies.

multiple myeloma
immunotherapy

FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who...

Hematologic Malignancies
Multiple Myeloma

New Tool for Assessing Frailty Predicts Survival in Newly Diagnosed Multiple Myeloma

A new frailty index predicts overall survival for patients newly diagnosed with multiple myeloma, according to a study recently published in JCO Clinical Cancer Informatics (JCO CCI). This tool is important because frailty is a critical factor in treatment decision-making for many patients with...

Hematologic Malignancies
Multiple Myeloma
Immunotherapy

Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma

In May 2018, daratumumab (Darzalex) was approved for use in combination with VMP (bortezomib, melphalan, and prednisone) in the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1 Supporting Efficacy Data Approval was based on...

multiple myeloma

Drug Combination Design for Multiple Myeloma Using an AI Platform

A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...

Multiple Myeloma

New Tool for Assessing Frailty in Patients With Newly Diagnosed Multiple Myeloma

A NEW “frailty index” may predict overall survival for patients newly diagnosed with multiple myeloma, according to a study published in JCO Clinical Cancer Informatics.1 Frailty is a critical factor in treatment decision-making for many patients with multiple myeloma, as many of these patients are ...

Multiple Myeloma

New Frontiers Being Explored in Multiple Myeloma

BEFORE TOO LONG, oncologists can expect to have an entirely new arsenal in the fight against multiple myeloma. Cutting-edge therapies on the near horizon were described in a presentation by Kenneth Anderson, MD, at the 2018 American Association of Cancer Research’s (AACR’s) inaugural conference on...

multiple myeloma

FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells, which prevents them from being...

multiple myeloma

New Tool for Assessing Frailty May Aid in Predicting Survival in Newly Diagnosed Multiple Myeloma

A new frailty index may aid in predicting overall survival for patients newly diagnosed with multiple myeloma, according to a study published by Mian et al in JCO Clinical Cancer Informatics. This tool is important because frailty is a critical factor in treatment decision-making for ...

multiple myeloma

FDA Grants Fast Track Designation to Galinpepimut-S in Multiple Myeloma

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

multiple myeloma

Phase III TOURMALINE-MM3 Trial of Ixazomib as Maintenance Therapy in Patients With Multiple Myeloma Posttransplant

The randomized, phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral ixazomib (Ninlaro) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) vs placebo. The trial evaluated the effect of ixazomib as a...

Multiple Myeloma

Expert Point of View: Parameswaran Hari, MD

FORMAL DISCUSSANT Parameswaran Hari, MD, of the Medical College of Wisconsin, Milwaukee, was impressed by many aspects of the bb2121 study, which represents the “largest and most mature” data set for the chimeric antigen receptor (CAR) T-cell approach in myeloma, he noted.  According to Dr. Hari,...

Multiple Myeloma
Immunotherapy

CAR T-Cell Therapy: Updated Data Remain Favorable in Heavily Pretreated Patients With Myeloma

IN AN UPDATE of a phase I trial, a heavily pretreated population of patients with multiple myeloma continued to respond to the chimeric antigen receptor (CAR) T-cell therapy bb2121.1 The results presented at the 2018 ASCO Annual Meeting confirmed previous findings for bb2121 in the dose-escalation...

multiple myeloma

CAR T Cells Targeting B-Cell Maturation Antigen in Poor-Prognosis Relapsed Multiple Myeloma

In a first-in-human study reported in the Journal of Clinical Oncology, Brudno et al found that chimeric antigen receptor (CAR) autologous T cells targeting B-cell maturation antigen (BCMA) produced responses in patients with poor-prognosis relapsed multiple myeloma. Study Details The current...

multiple myeloma

Once- vs Twice-Weekly Carfilzomib in Relapsed or Refractory Multiple Myeloma

An interim analysis of the phase III ARROW trial reported in The Lancet Oncology by Moreau et al indicated that a higher-dose once-weekly schedule of carfilzomib was associated with prolonged progression-free survival vs a twice-weekly schedule in patients with relapsed or refractory multiple...

multiple myeloma

EHA 2018: Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone vs Pomalidomide/Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma

The ELOQUENT-3 trial, an international phase II study evaluating the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, achieved its primary endpoint, showing a statistically significant and clinically...

lung cancer
multiple myeloma

Studies of Daratumumab in Combination With Anti–PD-L1 Agents Stopped

On May 26, Genmab A/S announced that following a planned review, the Data Monitoring Committee (DMC) has recommended that the phase Ib/II study (CALLISTO/LUC2001) of daratumumab (Darzalex) in combination with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) vs ...

multiple myeloma
immunotherapy

2018 ASCO: Pomalidomide, Bortezomib, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

For patients with multiple myeloma who have been treated with lenalidome (Revlimid) but have relapsed and not responded to other therapy, a three-drug combination can significantly extend the time in which the disease is held in check. The findings of the phase III OPTIMISMM trial were presented by ...

multiple myeloma

Aviva C. Krauss, MD, on Multiple Myeloma: Treatment Trials Analysis

Aviva C. Krauss, MD, of the U.S. Food and Drug Administration, discusses findings on an FDA analysis of immune-related adverse events and response to pembrolizumab in multiple myeloma (Abstract 8008).

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...

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