On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti™) for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.

Clinicians often use combination cancer therapies to overcome treatment resistance, and one of the newest options for certain patients with multiple myeloma is isatuximab, a monoclonal antibody (mAb). Approved for use in combination with pomalidomide plus dexamethasone to treat adults with relapsed or refractory multiple myeloma who have received at least two prior therapies, isatuximab prolonged progression-free survival by nearly six months and produced an overall response rate of more than 60% in the drug’s clinical trials.

On November 30, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™), carfilzomib (Kyprolis^®), and dexamethasone for adult patients with relapsed or refractory multiple myeloma who received one to three prior lines of therapy.

A first-of-its-kind antibody-drug conjugate for multiple myeloma, belantamab mafodotin-blmf (Blenrep) received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2020. The approval was based on clinical trial findings that demonstrated a 31% overall response rate that lasted at least six months in 73% of responders.

On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa^®) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. 

On March 27, 2021, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma), for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma. 

On February 26, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto^®) in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38–directed monoclonal antibody.

On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio^®) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refectory multiple myeloma who have received at least one prior therapy. 

Multiple myeloma is a plasma cell neoplasm and the second most common hematologic malignancy in the United States, although overall incidence rates are relatively low at approximately 32,000 annually. The overall five-year survival rate is 52%, and most people are diagnosed with the disease in later stages.

On March 2, 2020, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa^®) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

On September 26, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex^®) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.

Three cytogenetic subtypes are particularly responsible for the increased incidence of multiple myeloma in people of African descent, according to the results of a study published in Blood Cancer Journal.

Patients with multiple myeloma are at increased risk for early death from infection after high-dose therapy and autologous stem cell transplantation (ASCT), according to the results of a study published in the American Journal of Hematology.

As new therapies come to market, patients with multiple myeloma have more treatment options that are improving outcomes and extending overall survival. However, the most effective options involve multidrug combinations and continuous maintenance therapy, which can result in cumulative toxicities and the potential for oncologic emergencies.

Adding bortezomib to combination therapy with lenalidomide and dexamethasone may improve progression-free and overall survival in patients with newly diagnosed multiple myeloma. The study findings were published in Lancet.

On February 22, 2017, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid^®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.

An interview with Beth Faiman, PhD, CNP, and Kimberly Noonan, NP

This content was developed by ONS, Beth Faiman, PhD, CNP, and Kimberly Noonan, NP, and is sponsored by Amgen. Faiman and Noonan received no payment for their participation.