CC-93269 for Multiple Myeloma

Recruiting at 73 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, Other cancers

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

Compensation: Varies

Number of Visits: Unknown

183 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. Participants should be fairly active and able to care for themselves (ECOG Performance Status of 0 or 1) and have measurable signs of the disease. They can't join if they've had certain stem cell transplants recently, are dealing with another cancer needing treatment, or if their myeloma affects the central nervous system.

Inclusion Criteria

My multiple myeloma has come back and is not responding to treatment.

I am fully active or can carry out light work.

You must have a disease that can be measured by a special laboratory.

Exclusion Criteria

My multiple myeloma has spread to my brain and is causing symptoms.

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

I had a stem cell transplant less than a year ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluation of safety and tolerability of escalating doses of CC-93269 to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD)

28-day cycles, up to 60 months

Monthly visits

Dose Expansion

Further evaluation of safety and efficacy of CC-93269 at or below the MTD in selected expansion cohorts

28-day cycles, up to 60 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• CC-93269

Trial Overview The study tests CC-93269, a new therapy designed to engage T cells in attacking cancer cells. It's an early-phase trial where doses will be increased gradually (Parts A and C) before being given to more patients at those levels (Parts B and D). The goal is to find out how safe it is and what effects it has on this type of blood cancer.

How Is the Trial Designed?

Group I: Administration of CC-93269 Experimental Treatment 1 Intervention

CC-93269 will be administered to each patient on a 28-day cycle

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

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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