Multiple Myeloma Clinical Trials

Our program has a solid foundation of experience and patient care excellence with clinical trials. Under the leadership of Ajai Chari, MD , our clinical trials program provides access to novel, life-saving treatment approaches that incorporate vaccines and new agents that are often not available outside the clinical trial setting.

We offer patients emerging, promising therapies and new drugs with the goal of improving outcomes. We maximize opportunities for cutting-edge care through Mount Sinai-initiated clinical trials, as well as collaborative multi-center trials and partnerships with pharmaceutical companies and institutions like the Multiple Myeloma Research Foundation. This is especially important for patients who have exhausted more standard treatments.

Having access to a broad portfolio of clinical trials enables us to provide a full array of options for the best care available today. Every clinical trial has specific eligibility criteria. Depending on the stage of your disease, exposure to prior therapies, and overall health, you may be eligible to participate in a clinical trial. Your doctor will determine whether you are a candidate for a clinical trial and are likely to benefit from it.

Our complete list of clinical trials includes trials that are open to patient enrollment as well as those that are no longer open to enrollment but that are still following participating patients. The following clinical trials are open to patient enrollment.

Our treatment approach emphasizes the translation of scientific discovery to clinical applications. Clinical trials let us test new treatments in a safe, structured manner and collect data that enables statistically valid analysis. They are instrumental in advancing approval of new drugs and therapies that are beneficial to patients. Our clinical trials research program has played a pivotal role in the approval by the U.S. Food and Drug Administration (FDA) of many new drugs, including Carfilzomib, Pomalidomide, Elotuzumab, Daratumumab, Ixazomib, and Selinexor. We would not have been able to achieve this progress without patient participation in clinical trials.

Many questions remain about the causes of myeloma and related diseases, mechanisms of resistance to therapies, and personalization of treatment. Clinical trials can help answer these questions. We are also exploring development of new options for patients who have exhausted currently available therapies.

If you are eligible for a trial, we will talk with you about the “Informed Consent” form, which describes the study and its potential benefits and safety concerns. You will have time to review this document, and we will answer any questions you may have as you decide if you want to participate.

Some of our clinical trials are only open to patients at Mount Sinai. With our large patient volume, these “investigator-initiated” trials can enroll enough patients for statistically valid data. We also conduct studies together with pharmaceutical companies that are developing new drugs based on our findings as well as discoveries from other laboratories. For example, we are participating in Celgene’s Chimeric Antigen Receptor (CAR)-T cell clinical trial, an innovative immunotherapy approach with promising results to date. In this study, T-cells from myeloma patients are genetically engineered to recognize a protein known as B-cell maturation antigen (BCMA) found on malignant plasma cells. Once injected back into the patient, these altered T-cells seek out and kill BCMA-containing cells.

In some cases, clinical trials are conducted at multiple centers, such as the CoMMpass study with the Multiple Myeloma Research Foundation. This approach enables more patients to participate and helps us more quickly gather the statistical results necessary to gain FDA approval of new drugs.

For more information on cancer clinical trials, visit the National Cancer Institute website.

Clinical Trials Open to Patient Enrollment 

Our complete list of clinical trials includes trials that are open to patient enrollment as well as those that are no longer open to enrollment but that are following participating patients. The following clinical trials are open to patient enrollment

Smoldering Multiple Myeloma

  • A Phase 2 Study of the Effect of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib on Disease Response in Patients With High Risk Smoldering Multiple Myeloma
    GCO# 16-1867, ClinicalTrials.gov Identifier: NCT02943473

Newly Diagnosed Multiple Myeloma

  • A Phase 2 Study of Subcutaneous Daratumumab in Combination with Dose-Attenuated Bortezomib, Lenalidomide, and Dexamethasone in Elderly Newly Diagnosed Multiple Myeloma Patients
    GCO# 19-0944, ClinicalTrials.gov Identifier pending

Relapsed Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

  • A Phase I Study of the Combination of a Selective Inhibitor of Nuclear Export, Selinexor, with Carfilzomib and Dexamethasone in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma
    GCO# 14-2001, ClinicalTrials.gov Identifier: NCT02199665
  • Oral ONC201 in Relapsed/Refractory Multiple Myeloma
    GCO# 17-1711,ClinicalTrials.gov Identifier: NCT02863991
  • A Phase 1b Study of SAR65098 (Anti-CD38 mAb) in Combination with Carfilzomib for the Treatment of Relapsed or Refractory Multiple Myeloma
    GCO# 16-0568,ClinicalTrials.gov Identifier: NCT01084252
  • A Phase 1B/2A Multicenter, Open-Label, Dose-Escalation Study to Determine the MTD, Assess the Safety, Tolerability, PKs and Efficacy of CC-220 Monotherapy and in Combination with Other Treatments in Subjects Relapsed and Refractory Multiple Myeloma
    GCO# 40-5054, ClinicalTrials.gov Identifier: NCT02199665
  • A 1/2a Open-label, Dose-Escalation Study to Investigate the Safety and Tolerability, Efficacy, PKs, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Patients with Relapsed/Refractory Multiple Myeloma
    GCO# 40-5043 ClinicalTrials.gov Identifier: NCT03439280

Immunotherapy for Relapsing/Refractory Myeloma

CAR T-cell Therapy

  • A Phase 2, Multicohort Open-Label Stud of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma
    GCO# 40-5112, ClinicalTrials.gov Identifier: NCT04133636
  • A Phase 2, Multi-Cohort, Open-Label Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects with Clinical High-Risk Multiple Myeloma
    GCO# 40-5076, ClinicalTrials.gov Identifier: NCT03601078
  • A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of bb2121 Vs Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma
    GCO# 40-5083 ClinicalTrials.gov Identifier: NCT03651128
  • A Phase 1, Open-Label, Dose-Escalation, PK, PD Study of the Safety and Efficacy of CAR2 Anti-CD38 A@ CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma
    GCO# 19-0814, ClinicalTrials.gov Identifier: NCT03464916
  • A Phase 1b-2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Relapsed or Refractory Multiple Myeloma
    GCO# 18-1068, ClinicalTrials.gov Identifier: NCT03548207
  • A Phase 1, Multicenter, Open-Label Study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells in Subjects with Relapsed and/or Refractory Multiple Myeloma. GCO # 20-2042, ClinicalTrials.gov Identifier: NCT04394650
  • A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma GCO 40-5112, ClinicalTrials.gov Identifier: NCT04133636

Antibody Therapy

  • A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized GPRC5D x CD3 DuoBody® Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
    GCO# 17-2163,ClinicalTrials.gov Identifier: NCT03399799
  • A Phase 1, First-in-Human, Open-Label Dose Escalation Study of JNJ-64007957, a Humanized BCMA x CD3 DuoBody Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
    GCO# 18-1068, ClinicalTrials.gov Identifier: NCT03145181
  • A Phase I/2 FIH Study of REGN5458 (Anti-BCMA X ANTI-CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma
    GCO# 19-0138, ClinicalTrials.gov Identifier: NCT03761108
  • A Phase 1, First-in-Man, Multicenter, Open-Label, Two Part Dose-Escalation and Cohort Expansion Study of Single-Agent GBR 1342 in Subjects with Previously Treated Multiple Myeloma
    GCO# 18-1328, ClinicalTrials.gov Identifier: NCT03309111
  • A Phase 1, Multicenter Open Label, Dose Finding Study Of CC-99712, A BCMA Antibody Drug Conjugate in Subjects with Relapsed and Refractory Multiple Myeloma
    GCO# 19-2424, ClinicalTrials.gov Identifier: NCT04036461