A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04036461|
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : August 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CC-99712 Drug: BMS-986405||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||May 28, 2023|
|Estimated Study Completion Date :||May 27, 2025|
Experimental: Arm 1 (CC-99712 monotherapy)
CC-99712 will be administered via intravenous (IV) infusion once per 21-days on a Once every three weeks (Q3W) schedule, and once per 28-days on a Once every four weeks (Q4W) schedule
Experimental: Arm 2 (CC-99712 and BMS-986405 combination)
CC-99712 will be administered as indicated above. BMS-986405 will be administered orally TIW every week during a 21-day cycle (eg, Day 1, Day 3, Day 5, Day 8, Day 10, Day 12, Day 15, Day 17, and Day 19), with 48 hours between each dose with a week
Other Name: GSI (Gamma secretase inhibitor)
- Adverse Events (AEs) [ Time Frame: From enrollment until at least 42 days after completion of study treatment ]Number of participants with adverse event
- Maximum Tolerated Dose (MTD) in participants with relapsed and refractory MM [ Time Frame: Up to 28 days ]Is defined as the highest dose that causes DLTs in no more than 33% of patient population during the first cycle of treatment.
- Dose Limiting Toxicity (DLT) in participants with relapsed and refractory MM [ Time Frame: Up to 28 days ]Is defined as any of the following toxicities occurring within the DLT assessment window
- Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]Is defined as the proportion of participants who achieve a partial response or better (eg, Partial response (PR), Very good partial response (VGPR), Complete response (CR) or sCR), according to IMWG response criteria.
- Time to Response [ Time Frame: Up to 3 years ]Is defined as the time from the first CC-99712 dose date to the date of first documented response (PR or better).
- Duration of Response [ Time Frame: Up to 3 years ]Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
- Progression-free Survival (PFS) [ Time Frame: Up to 3 years ]Is defined as the time from the first dose of CC-99712 to progressive disease (PD) or death from any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 3 years ]Is defined as the time from the first dose of CC-99712 to death from any cause.
- Pharmacokinetics- Cmax [ Time Frame: Up to 3 years ]Maximum plasma concentration of drug
- Pharmacokinetics- Cmin [ Time Frame: Up to 3 years ]Minimum plasma concentration of drug
- Pharmacokinetics- AUC [ Time Frame: Up to 3 years ]Area under the curve
- Pharmacokinetics- tmax [ Time Frame: Up to 3 years ]Time to peak (maximum) serum concentration
- Pharmacokinetics- t1/2 [ Time Frame: Up to 3 years ]Half-life
- Pharmacokinetics- CL [ Time Frame: Up to 3 years ]Clearance
- Pharmacokinetics- Vss [ Time Frame: Up to 3 years ]Volume of Distribution
- Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection [ Time Frame: Up to 3 years ]Anti-CC-99712 antibodies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036461
|Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,||please email:||Clinical.Trials@bms.com|
|Contact: First line of the email MUST contain NCT # and Site #.|
|Study Director:||Eric Kim, MD||Celgene|