CC-92328 for Multiple Myeloma

Recruiting at 36 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celgene

Disqualifiers: CNS involvement, Recent transplants, HIV, HBV/HCV, others

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

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CC-92328 to see if it is safe and effective for patients with multiple myeloma that has come back or didn't respond to other treatments. The study will see if the drug can slow down or stop the cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had prior cancer treatments or investigational treatments within a certain time before starting the trial, which might imply a need to stop some medications. It's best to discuss your specific medications with the trial team.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with relapsed or refractory multiple myeloma who have tried other treatments without success. They must be able to perform daily activities with ease (ECOG PS of 0 or 1), understand the study, and follow its schedule. Women who can become pregnant and men must use effective birth control. People cannot join if they are pregnant, recently had certain vaccines or transplants, weigh under 40 kg, have active hepatitis B/C, HIV, or MM affecting the brain.

Inclusion Criteria

You must have a disease that can be measured.

I am 18 years old or older.

My multiple myeloma has returned or didn't respond to treatment, and I can't use or have failed all other treatments.

Exclusion Criteria

I had a stem cell transplant using my own cells less than 3 months ago.

I weigh 40 kg or less.

I haven't had cancer treatments or experimental drugs within the last 4 weeks or 5 half-lives, whichever is shorter.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation (Part A)

Participants receive escalating doses of CC-92328 to determine the maximum tolerated dose

28 days per cycle

Multiple visits per cycle

Monotherapy Dose Expansion (Part B)

Participants receive the determined dose of CC-92328 to further evaluate safety and efficacy

28 days per cycle

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks after last dose

Treatment Details

Interventions

• CC-92328

Trial Overview The trial tests CC-92328's safety and effectiveness in two parts: first by increasing doses to find a safe amount (Part A) and then giving this dose to more people to further assess its effects (Part B). It's aimed at those whose multiple myeloma has returned after treatment or hasn't responded to previous therapies.

Participant Groups

Group I: Administration of CC-92328 Experimental Treatment 1 Intervention

CC-92328 administered intravenously in 28-day cycles

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania