Cellular Therapies for Multiple Myeloma

Recruiting at 8 trial locations

Overseen By Carlyn Tan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Active CNS disease, definitive plan, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why certain treatments for multiple myeloma, such as stem cell transplants and CAR T-cell therapy, are not used more often. It examines how patients with relapsed or hard-to-treat multiple myeloma and their doctors make decisions about these advanced therapies. Individuals diagnosed with multiple myeloma after 2017, who have undergone two or more treatments, and are seeking to start a new treatment soon, might be suitable candidates. The study includes different groups of doctors, some who perform these therapies and others who refer patients for them. As an unphased trial, this study offers a unique opportunity to contribute to understanding treatment decisions and potentially improve future care options.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, CAR T-cell therapy demonstrated high success rates and manageable safety in patients with relapsed or hard-to-treat multiple myeloma. Some patients experienced cytokine release syndrome (CRS), where the immune system becomes overly active, and a few had other side effects like nerve problems. However, most side effects were manageable.

Research on hematopoietic stem cell transplantation, a procedure to replace damaged bone marrow, has shown a good balance of risks and benefits for treating relapsed multiple myeloma. Patients generally handle the procedure well, and it can effectively manage the disease.

Both treatments have shown promise in earlier studies, but they come with some risks. It is important to consult a healthcare provider to understand these risks better and determine if participating in a trial is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover what keeps patients with plasma cell disorders, like multiple myeloma, from accessing cutting-edge treatments such as cellular therapies. Unlike standard treatments that might include chemotherapy or targeted medications, cellular therapies like CAR T-cell therapy and stem cell transplants offer a more personalized approach by harnessing the body's own cells to fight cancer. The trial focuses on understanding the role of different physician groups in facilitating these advanced therapies, which could lead to broader access and better outcomes for patients. This could ultimately transform how these complex conditions are managed, making innovative treatments more accessible to those who need them.

What evidence suggests that this trial's treatments could be effective for relapsed/refractory multiple myeloma?

Research has shown that CAR T-cell therapy, which targets a protein called BCMA, effectively treats patients with relapsed or hard-to-treat multiple myeloma. Nearly half of the patients experience lasting benefits, with the treatment continuing to work over time. In this trial, some participants will receive care from physicians authorized to order and infuse CAR T cells.

For stem cell transplants, studies have shown mixed results. Some patients, particularly those at high risk, achieve long-term survival with this treatment. However, results can vary, and not every patient benefits equally. In this trial, other participants will receive care from physicians who can order and infuse both stem cells and CAR T cells. Both treatments offer hope, but their effectiveness can depend on individual patient factors. ^{2 3 4 6 7}

Who Is on the Research Team?

Heather Landau, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

You are willing to give permission after learning about the study.

You have started a new treatment for RRMM in the last 12 months before joining the study.

You can speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Gathering information about the use of hematopoietic cell transplantation and CAR T-cell therapy

Up to 76 months

Follow-up

Participants are monitored for safety and effectiveness after observational data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BCMA-targeted CAR T-cell Therapy

How Is the Trial Designed?

Group I: Physician Group 3: HCT and CAR Enabled Experimental Treatment 0 Interventions

These physicians can order and infuse stem cells and CAR T cells

Group II: Physician Group 2: CAR Enabled Experimental Treatment 1 Intervention

These physicians can order and infuse CAR T cells but not stem cells.

Group III: Physician Group 1: Primary Myeloma Therapy Experimental Treatment 1 Intervention

Physicians in this group refer for cellular therapy but do not perform the infusions.

Group IV: Participant Cohort 2 Experimental Treatment 5 Interventions

Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater

Group V: Participant Cohort 1 Experimental Treatment 5 Interventions

Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41019073/

Long-term follow-up of patients with relapsed/refractory ... BCMA CAR-T-cell therapy exhibits favorable safety and efficacy in advanced R/R MM. Long-term follow-up confirmed durable responses in 50% of ...

2. nature.com nature.com/articles/s41408-024-01191-8

CAR-T cell therapy in Multiple Myeloma: current status and ... Chimeric antigen receptor T-cell therapy targeting the B cell maturation antigen (BCMA) is now widely approved in relapsed refractory patients and is moving ...

3. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/2405/532395/Chimeric-Antigen-Receptor-T-Cell-Therapy-for

Chimeric Antigen Receptor T-Cell Therapy for Relapsed ... Out of 152 patients, 72 (47%) completed apheresis, and 70 (46%) patients received CAR T-cell therapy. The remaining 82 patients received ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00760

Long-Term (≥5-Year) Remission and Survival After ... For patients with heavily pretreated relapsed/refractory multiple myeloma (RRMM), previous studies report a median progression-free survival ( ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265025026217

Efficacy and Safety of CAR T-Cell Therapy in Relapsed/ ... The selection criteria were as follows: clinical trials with efficacy and/or safety outcomes of RRMM patients treated with CAR T cells. Data on response rates, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39763668/

Efficacy and safety of chimeric antigen receptor T cells ... Conclusion: GPRC5D CAR-T potentially demonstrates enhanced effectiveness relative to BCMA CAR-T in treating patients with RRMM. Therefore, ...

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1650568/full

Long-term follow-up of patients with relapsed/refractory ... Conclusion: BCMA CAR-T-cell therapy exhibits favorable safety and efficacy in advanced R/R MM. Long-term follow-up confirmed durable responses in 50% of the ...