CC-99712 for Multiple Myeloma

Recruiting at 49 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celgene

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

Compensation: Varies

Number of Visits: Unknown

47 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, CC-99712, alone or with another drug, BMS-986405, in patients with a type of blood cancer that has come back and doesn't respond to usual treatments. Researchers will gradually find the safest and most effective amount while checking for side effects and cancer treatment effectiveness.

Will I have to stop taking my current medications?

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

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma that has come back or hasn't responded to treatment. They must have measurable disease and be in good physical condition (ECOG PS of 0 or 1). It's not for pregnant women, those with HIV, brain involvement of MM, recent stem cell transplants, or active hepatitis B/C.

Inclusion Criteria

I am 18 years old or older.

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

You must have a specific, measurable health issue.

Exclusion Criteria

I am HIV positive.

Subject is a pregnant or lactating female.

I had a stem cell transplant less than 6 months ago or am on medication for graft-versus-host disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of CC-99712 to determine the maximum tolerated dose (MTD)

Up to 28 days

Multiple visits for dose administration and monitoring

Dose Expansion

Participants receive CC-99712 at or below the MTD to evaluate safety and efficacy

Up to 3 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

At least 42 days after completion of study treatment

Treatment Details

Interventions

• CC-99712

Trial Overview The study tests CC-99712 alone or with BMS-986405 on participants with relapsed/refractory multiple myeloma. Part A finds the highest dose they can give without bad side effects (MTD) and Part B checks how well it works at this dose.

Participant Groups

Group I: Arm 2 (CC-99712 and BMS-986405 combination) Experimental Treatment 2 Interventions

CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.

Group II: Arm 1 (CC-99712 monotherapy) Experimental Treatment 1 Intervention

CC-99712 will be administered via intravenous (IV) infusion.

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

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