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 : May 10, 2023
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|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 :||December 27, 2024|
|Estimated Study Completion Date :||May 26, 2025|
Experimental: Arm 1 (CC-99712 monotherapy)
CC-99712 will be administered via intravenous (IV) infusion.
Experimental: Arm 2 (CC-99712 and BMS-986405 combination)
CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.
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- Tmax [ Time Frame: Up to 3 years ]Time to peak (maximum) serum concentration
- Pharmacokinetics- AUC(TAU) [ Time Frame: Up to 3 years ]Area under the serum concentration time-curve
- Pharmacokinetics- CLT [ Time Frame: Up to 3 years ]Total body clearance of the drug from the serum
- Pharmacokinetics- Ctrough [ Time Frame: Up to 3 years ]Lowest concentration of drug immediately prior to administration of the next dose
- Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection [ Time Frame: Up to 3 years ]Anti-CC-99712 antibodies
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Participants must satisfy the following criteria to be enrolled in the study:
- 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
- Participant must have measurable disease.
- Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Participant has symptomatic central nervous system involvement of MM.
- Participant had a prior autologous stem cell transplant ≤ 3 months prior to starting CC-99712.
- Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99712 or is on systemic immunosuppression for graft-versus host disease.
- Subject is a pregnant or lactating female.
- Subject has known human immunodeficiency virus (HIV) infection.
- Subject has active hepatitis B or C (HBV/HCV) infection.
Other protocol-defined inclusion/exclusion criteria apply
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: BMS Study Connect Contact Center www.BMSStudyConnect.com||855-907-3286||Clinical.Trials@bms.com|
|Contact: First line of the email MUST contain NCT # and Site #.|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|
|Other Study ID Numbers:||
U1111-1231-9404 ( Other Identifier: WHO )
2020-004514-35 ( EudraCT Number )
|First Posted:||July 29, 2019 Key Record Dates|
|Last Update Posted:||May 10, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||See Plan Description|
|Access Criteria:||See Plan Description|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Relapsed and refractory
Antibody drug conjugate
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Gamma Secretase Inhibitors and Modulators
Molecular Mechanisms of Pharmacological Action