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Multiple Myeloma

Strong Showing for Anti-CD38 Antibodies in Multiple Myeloma

An investigational class of agents in multiple myeloma, the anti-CD38 monoclonal antibodies, could be the next blockbusters in this malignancy, myeloma experts predicted at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. Anti-CD38 antibodies target multiple myeloma...

Multiple Myeloma

Oral Proteasome Inhibitors Advancing in Multiple Myeloma Trials

Two orally administered proteasome inhibitors—oprozomib and ixazomib—looked encouraging in multiple myeloma studies presented at the 2014 ASH Annual Meeting and Exposition. Study Details for Oprozomib Oprozomib, given as a single agent in a dose-escalation study of heavily pretreated patients,...

multiple myeloma

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...

multiple myeloma

FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has 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...

multiple myeloma

From ASH 2014: What’s New in the Myeloma Treatment Arsenal?

At the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, attendance at many multiple myeloma sessions outnumbered the room size, as data from studies of novel agents, such as the monoclonal antibodies, and from key trials, such as ASPIRE, drew crowds. The ASCO Post covered...

multiple myeloma

Five Questions Can Guide the Treatment of Relapsed Myeloma

Joseph Mikhael, MD, MEd, myeloma expert at the Mayo Clinic in Arizona, Scottsdale, and Associate Dean of the Mayo School of Graduate Medical Education, considers five questions when selecting treatment for patients with multiple myeloma who relapse. “With prolonged survival, which approaches 10...

multiple myeloma

Panobinostat in Combination With Bortezomib‑Dexamethasone in Previously Treated Multiple Myeloma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On February 23, 2015, panobinostat (Farydak) was granted...

multiple myeloma

Lenalidomide in Combination With Dexamethasone in Newly Diagnosed Multiple Myeloma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On February 18, 2015, the indication for lenalidomide...

multiple myeloma

Increased Progression-Free Survival With Addition of Carfilzomib to Lenalidomide/Dexamethasone in Relapsed Multiple Myeloma

In a planned interim analysis of the phase III ASPIRE trial reported in The New England Journal of Medicine, A. Keith Stewart, MB, ChB, of the Mayo Clinic, Scottsdale, Arizona, and colleagues found that the addition of the proteasome inhibitor carfilzomib (Kyprolis) to lenalidomide...

multiple myeloma

The ASPIRE Trial of Carfilzomib in Relapsed Myeloma: A Major Step Forward

Currently in myeloma, there are at least five new agents that are either approved or in the late-stage of development with impending approval. Major questions in the field relate to how we, as clinicians, will use these new agents and where they will fit in the overall treatment schema. The phase...

multiple myeloma

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 conversion of ...

Multiple Myeloma
Geriatric Oncology

‘Frailty Profile’ Predicts Survival and Toxicities in 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 clinical...

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Pancreatic Cancer

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2015 Updates

For 2 decades, the NCCN Guidelines® have been recognized as the standard of cancer care in the United States, combining evidence, experience, and choice, so that multidisciplinary cancer treatment teams—including patients—are empowered to make informed decisions about cancer care,” said Robert W....

Multiple Myeloma

Novel Agent Elotuzumab Added to Lenalidomide/Dexamethasone Extends Progression-Free Survival in Multiple Myeloma

The monoclonal antibody elotuzumab, given with lenalidomide (Revlimid) and dexamethasone, extended progression-free survival by a median of 5 months, compared with lenalidomide/dexamethasone alone, in the eagerly awaited phase III ELOQUENT-2 trial, which will be presented at the 2015 ASCO Annual...

Multiple Myeloma

Single-Agent Daratumumab Activity Deemed ‘Remarkable’ in Refractory Multiple Myeloma

Heavily pretreated patients with multiple myeloma achieved rapid, durable, and deepening responses to the anti-CD38 monoclonal antibody daratumumab, in a phase II study presented at the 2015 ASCO Annual Meeting.1 “Daratumumab showed remarkable single-agent activity in heavily pretreated and...

Multiple Myeloma

Carfilzomib/Dexamethasone Doubles Progression-Free Survival vs Bortezomib/Dexamethasone in Patients With Relapsed Multiple Myeloma

In the first head-to-head study comparing two proteasome inhibitors in relapsed multiple myeloma, carfilzomib (Kyprolis)/dexamethasone provided a doubling in progression-free survival, compared with bortezomib (Velcade)/dexamethasone.1 Results of the phase III ENDEAVOR trial of the two regimens in...

multiple myeloma

Collaborating Toward a Cure

We’ve seen how dramatically patients’ lives can change when they are matched with the right treatment at the right time in their disease course. Although this is still an exception and not the rule, we believe collaborative research approaches will make this kind of precision medicine a reality for ...

Multiple Myeloma

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 patients in the United States. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The...

Multiple Myeloma

Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On July 24, 2015, carfilzomib (Kyprolis) was approved for use in...

Multiple Myeloma

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. In the United States, there are nearly...

Multiple Myeloma

Elotuzumab Ushers in a New Era in Myeloma Therapy

The long wait for monoclonal antibodies for the treatment of multiple myeloma is over. In the landmark ELOQUENT-2 study, reviewed in this issue of The ASCO Post, Lonial and colleagues convincingly demonstrate the effectiveness of elotuzumab, a monoclonal antibody directed against SLAMF7, in the...

Multiple Myeloma

Adding Elotuzumab to Lenalidomide Plus Dexamethasone Improves Progression-Free Survival in Refractory Multiple Myeloma

In an interim analysis of the phase III ELOQUENT-2 trial reported in The New England Journal of Medicine, Sagar Lonial, MD, of Emory University School of Medicine, Meletios Dimopoulos, MD, of National and Kapodistrian University of Athens, and colleagues found that the addition of elotuzumab to...

Multiple Myeloma

FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma

Bristol-Myers Squibb and AbbVie recently 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...

Multiple Myeloma

CAR T-Cell Immunotherapy Saved My Life

I have always prided myself on being healthy and fit, so when I started experiencing a chronic cough, difficulty breathing, and pain in my ribs and back, I thought they were the inevitable symptoms of a severe cold. At 42 and the mother of three children, it was inconceivable to me that I could...

Multiple Myeloma

Daratumumab Approved in Multiple Myeloma

The U.S. Food and Drug Administration has granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome...

Multiple Myeloma

Ixazomib in Previously Treated Multiple Myeloma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 20, 2015, ixazomib (Ninlaro) was approved by the U.S....

Multiple Myeloma

Daratumumab in Previously Treated Multiple Myeloma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On November 16, 2015, daratumumab injection (Darzalex) was...

Multiple Myeloma

FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts with...

Multiple Myeloma

Better Quality of Life With Melphalan and Prednisone Used With Lenalidomide Than With Thalidomide

A phase III Eastern Cooperative Oncology Group (ECOG) trial (E1A060) comparing melphalan, prednisone, and thalidomide (Thalomid) with melphalan, prednisone, and lenalidomide (Revlimid) in elderly patients with untreated multiple myeloma found that at the end of the induction period, patients...

Multiple Myeloma

Hoping for a Cure

Unless you have a type of cancer that can be surgically removed or blasted into oblivion with chemotherapy or radiation therapy rendering a cure, having a chronic cancer like multiple myeloma robs you of a normal life. Learning to accept that fact is an adjustment. I was diagnosed with multiple...

Multiple Myeloma

Impressive Results With Daratumumab Plus Lenalidomide/Dexamethasone in Multiple Myeloma

The anti-CD38 monoclonal antibody daratumu­mab (Darzalex) took center stage among multiple myeloma studies presented at the 57th American Society of Hematology Annual Meeting and Exposition. In relapsed/refractory patients, daratumumab plus lenalidomide (Revlimid)/dexamethasone yielded an 81%...

multiple myeloma

Sagar Lonial, MD, on Multiple Myeloma: How I Treat Newly Diagnosed Patients

Sagar Lonial, MD, of Emory University School of Medicine, summarizes his educational session on this vital topic.

multiple myeloma

Sagar Lonial, MD, and Torben Plesner, MD, on Multiple Myeloma: Updated Results of the Phase I/II GEN503 Study

Sagar Lonial, MD, of Emory University School of Medicine, and Torben Plesner, MD, of Vejle Hospital, discuss the latest findings on the use of daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (Abstract 507).

multiple myeloma

James N. Kochenderfer, MD, on Multiple Myeloma: Results of a First-in-Humans Clinical Trial

James N. Kochenderfer, MD, of the National Cancer Institute, reports on remissions of multiple myeloma during a trial of T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor (Abstract 99).

multiple myeloma

S. Vincent Rajkumar, MD, on Multiple Myeloma: Newly Approved Drugs

S. Vincent Rajkumar, MD, of the Mayo Clinic, summarizes a special FDA-sponsored session on the three myeloma drugs that were approved this November––daratumumab, ixazomib, and elotozumab––and their current and future roles in treating the disease.

multiple myeloma

S. Vincent Rajkumar, MD, on Advances in Myeloma

S. Vincent Rajkumar, MD, of the Mayo Clinic, summarizes his education session on the evolving diagnostic criteria for myeloma, which focused on smoldering disease and when it becomes an “open flame.”

multiple myeloma

David Henry, MD, on Multiple Myeloma: Expert Perspective

David Henry, MD, of Pennsylvania Hospital, discusses the exciting developments in multiple myeloma treatment, including the three new drugs approved for the disease in November 2015.

multiple myeloma

Julie Vose, MD, MBA, and Rafat Abonour, MD, on Multiple Myeloma: The Path to a Cure

Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and Rafat Abonour, MD, of Indiana University Simon Cancer Center, discuss the session that he chaired on the question of whether researchers can design therapy that addresses the heterogeneity of the disease and eradicate most if not all of the myeloma clones.

multiple myeloma

James N. Kochenderfer, MD, on Preventing Progressive Malignancy After Stem Cell Transplant

James N. Kochenderfer, MD, of the National Cancer Institute, discusses a clinical trial of allogeneic T cells expressing an anti-CD19 chimeric antigen receptor, which caused remissions of B-cell cancers after stem cell transplant, without causing graft-vs-host disease (Abstract LBA1).

multiple myeloma

ASH 2015: Multiple Myeloma Patient Study Shows Promise for Natural Killer Cells

A first-in-human phase I study of multiple myeloma patients combined expanded cord blood-derived natural killer cells with transplantation of a patient’s own stem cells and high-dose chemotherapy, with little or none of the side effects seen with current treatments. Results from the clinical...

multiple myeloma

ASH 2015: Updated Results of the Phase I/II GEN503 Study of Daratumumab in Multiple Myeloma

In a study update presented by Plesner et al at the 57th American Society of Hematology (ASH) Annual Meeting, daratumumab (Darzalex) was shown to be safe and effective in combination with lenalidomide (Revlimid) and dexamethasone in patients with relapsed/refractory multiple myeloma (Abstract 507). ...

multiple myeloma

ASH 2015: Updated Results of Phase III Tourmaline-MM1 Study of Ixazomib in Multiple Myeloma

In a study presented by Moureau et al at the 57th American Society of Hematology (ASH) Annual Meeting, ixazomib (Ninlaro), a recently approved oral proteasome inhibitor, significantly extended progression-free survival for patients with relapsed and/or refractory multiple myeloma (Abstract 727)....

multiple myeloma

ASH 2015: First-in-Human Trial Using Engineered Cells to Target Multiple Myeloma Shows Early Promise

A study (Abstract LBA1) to be reported by Abbas Ali et al at the 57th American Society of Hematology (ASH) Annual Meeting demonstrated promising early outcomes of a first-in-human trial using a patient’s own genetically modified immune cells to eradicate multiple myeloma. The study...

hematologic malignancies
multiple myeloma

Study Finds Better Outcome With Melphalan Plus ASCT vs Chemotherapy Plus Lenalidomide Consolidation in Multiple Myeloma

In a phase III trial reported in The Lancet Oncology, Gay et al found that progression-free survival was shorter with lenalidomide (Revlimid) plus chemotherapy vs high-dose melphalan plus autologous stem cell transplantation in transplant-eligible patients with multiple myeloma, with no significant ...

multiple myeloma

FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

The U.S. Food and Drug Administration (FDA) granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts...

multiple myeloma

FDA Approves Ixazomib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

The U.S. Food and Drug Administration (FDA) granted approval for ixazomib (Ninlaro) in combination with two other agents to treat patients with multiple myeloma who have received at least one prior therapy. “As we learn more about the underlying biology of multiple myeloma, we are encouraged ...

multiple myeloma

FDA Approves Daratumumab for Patients With Previously Treated Multiple Myeloma

Today the U.S. Food and Drug Administration granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome ...

multiple myeloma

Anti-CD19 Chimeric Antigen Receptor T-Cell Treatment Produces Response in Patient With Refractory Multiple Myeloma

As reported by Garfall et al in The New England Journal of Medicine, a patient with refractory multiple myeloma who had undergone prior autologous stem cell transplantation and multiple lines of therapy exhibited a complete response to a second autologous transplantation followed by infusion of...

multiple myeloma
issues in oncology
issues in oncology

Adding Lenalidomide to Melphalan/Prednisone Yields Better Quality of Life Than Thalidomide in Elderly Patients With Multiple Myeloma

A phase III Eastern Cooperative Oncology Group (ECOG) trial (E1A060) comparing melphalan, prednisone, and thalidomide (Thalomid) (MPT-T) with melphalan, prednisone, and lenalidomide (Revlimid) (mPR-R) in elderly patients with untreated multiple myeloma found that at the end of the induction period, ...

multiple myeloma

Study Finds CD38-Targeted Antibody Daratumumab Active in Relapsed Multiple Myeloma

In a phase I/II trial reported in The New England Journal of Medicine, Lokhorst et al found that the CD38-targeting human IgG1κ monoclonal antibody daratumumab had an acceptable safety profile and produced durable responses in relapsed multiple myeloma. Study Details In the dose-escalation...

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