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Monoclonal Antibodies

Novel Drug Combinations for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2)

Eastern Cooperative Oncology Group performance status of 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial aims to find an effective, safe dose of drugs to treat multiple myeloma, a cancer of the blood.

Who is the study for?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. They must have had at least one but not more than three prior treatments and be in good physical condition. People can't join if their cancer has spread to the brain or they have other health issues that could affect the study results.Check my eligibility

What is being tested?

The trial is testing BMS-986393 combined with alnuctamab, mezigdomide, and iberdomide to find a safe dose for patients whose multiple myeloma has relapsed or isn't responding to treatment.See study design

What are the potential side effects?

Possible side effects of these drugs may include fatigue, digestive problems, blood disorders, increased risk of infections, and reactions at the infusion site. The exact side effects will depend on how well participants tolerate BMS-986393.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have multiple myeloma that has come back or didn't respond to treatment, and I've had 1-3 prior treatments.

Select...

I am fully active or can carry out light work.

Select...

My multiple myeloma can be measured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish recommended Phase 2 dose (RP2D)

Incidence of AEs leading to discontinuation

Incidence of adverse events (AEs)

+3 more

Secondary outcome measures

Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)]

Complete response rate (CRR)

Maximum observed concentration (Cmax)

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C: BMS-986393 + IberdomideExperimental Treatment2 Interventions

Group II: Arm B: BMS-986393 + MezigdomideExperimental Treatment2 Interventions

Group III: Arm A: BMS-986393 + AlnuctamabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mezigdomide

2023

Completed Phase 1

~40

Iberdomide

2021

Completed Phase 1

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLead Sponsor

14 Previous Clinical Trials

1,616 Total Patients Enrolled

5 Trials studying Multiple Myeloma

347 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,508 Previous Clinical Trials

3,370,312 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,176 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this clinical trial?

"The clinicaltrials.gov site indicates that this medical trial, which originated on December 31st 2023 and last modified November 2nd 2023, is no longer actively seeking participants. However, there are still 830 other opportunities currently available to possible candidates."

Answered by AI

Has the FDA given its stamp of approval to a combination therapy comprised of BMS-986393 and Alnuctamab?

"The safety of Arm A: BMS-986393 + Alnuctamab was assessed at 1, as this is an early phase trial with minimal clinical evidence to support its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

2024. "A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121843.

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