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Monoclonal Antibodies

CC-99712 for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is ≥ 18 years of age at the time of signing the ICF.
Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new drug, CC-99712, for safety and effectiveness in people with multiple myeloma who have relapsed or are refractory to other treatments. The trial will have two parts: dose escalation and expansion. The first part will test different doses of the drug to find the maximum tolerated dose. The second part will test the safety and efficacy of the drug at or below the maximum tolerated dose in a larger group of people.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects are not detailed here but typically include reactions related to the immune system's response to the drug, infusion-related reactions, fatigue, digestive issues and potential blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My multiple myeloma has come back or is not responding to treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Adverse Events (AEs)
Dose Limiting Toxicity (DLT) in participants with relapsed and refractory MM
Maximum Tolerated Dose (MTD) in participants with relapsed and refractory MM
Secondary outcome measures
Duration of Response
Overall Response Rate (ORR)
Overall Survival (OS)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 (CC-99712 and BMS-986405 combination)Experimental Treatment2 Interventions
CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.
Group II: Arm 1 (CC-99712 monotherapy)Experimental Treatment1 Intervention
CC-99712 will be administered via intravenous (IV) infusion.

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,811 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,703 Patients Enrolled for Multiple Myeloma
Eric Kim, MDStudy DirectorCelgene
1 Previous Clinical Trials
100 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,370 Total Patients Enrolled
72 Trials studying Multiple Myeloma
25,127 Patients Enrolled for Multiple Myeloma

Media Library

CC-99712 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04036461 — Phase 1
Multiple Myeloma Research Study Groups: Arm 1 (CC-99712 monotherapy), Arm 2 (CC-99712 and BMS-986405 combination)
Multiple Myeloma Clinical Trial 2023: CC-99712 Highlights & Side Effects. Trial Name: NCT04036461 — Phase 1
CC-99712 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04036461 — Phase 1

Frequently Asked Questions

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

What are the primary goals of this research endeavor?

"This clinical trial will span a maximum of 28 days and its primary assessment is to evaluate the occurrence of Adverse Events (AEs). Secondary objectives include measuring Total body clearance, Area under the serum concentration time-curve, and Overall Survival."

Answered by AI

Is enrollment in this trial currently available?

"Data available on clinicaltrials.gov indicates this medical trial is actively looking for volunteers, having been initially posted August 26th 2019 and recently revised November 7th 2022."

Answered by AI

Are there numerous facilities carrying out this experiment in Canada?

"This clinical trial is taking place at Local Institution - 201 in Montreal, Quebec, Princess Margaret Cancer Centre in La Jolla, California, Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal in Dallas Texas and 13 different other medical centres."

Answered by AI

How many participants is this trial recruiting?

"To complete the trial, 160 eligible patients must be recruited. These individuals may apply to participate at either Local Institution - 201 in Montreal or Princess Margaret Cancer Centre in La Jolla."

Answered by AI

What potential risks can CC-99712 pose to individuals?

"Our internal risk assessment gave CC-99712 a score of 1 due to its status as a Phase 1 trial, which only has preliminary safety and efficacy data."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma
2019. "A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04036461.
~11 spots leftby Aug 2024
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