Nivolumab for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Tiffany Drennan, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Active infection, Autoimmune disease, Transplant, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to evaluate if treatment with adjuvant nivolumab improves depth of response in patients with relapsed refractory multiple myeloma (RRMM) who achieve a less-than-ideal response to idecaptagene vicleucel.

Research Team

Barry A Paul, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

Adults with relapsed refractory multiple myeloma who've had a suboptimal response to idecabtagene vicleucel. They should be able to follow the study plan, have good performance status, and recovered from previous therapy effects. Exclusions include certain infections, other cancers within 2 years (with exceptions), recent transplants, known allergies to study drugs, active autoimmune diseases or lung issues.

Inclusion Criteria

I can follow the study's procedures as required.

I am fully active or can carry out light work.

I received my idecabtagene vicleucel infusion between 3 to 6 weeks ago.

Exclusion Criteria

I have been diagnosed with Waldenstrom macroglobulinemia, POEMS syndrome, or amyloidosis.

I do not have an active infection needing treatment, uncontrolled HIV, hepatitis B or C, or active TB.

I have been cancer-free for 2 years, except for certain skin, cervical, or bladder cancers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant nivolumab every 4 weeks for 2 cycles

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

Long-term follow-up

Participants are assessed for progression-free survival and overall survival

4 years

Treatment Details

Interventions

• Nivolumab

Trial Overview The trial is testing if nivolumab can improve treatment outcomes in patients with multiple myeloma after receiving idecabtagene vicleucel but not achieving an ideal response. It's about whether adding nivolumab makes the initial treatment more effective.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Nivolumab

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania