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A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036461
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-99712 Drug: BMS-986405 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 (CC-99712 monotherapy)
CC-99712 will be administered via intravenous (IV) infusion.
 Drug: CC-99712
CC-99712
Experimental: Arm 2 (CC-99712 and BMS-986405 combination)
CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.
 Drug: CC-99712
CC-99712

Drug: BMS-986405
BMS-986405
Other Name: GSI (Gamma secretase inhibitor)


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: From enrollment until at least 42 days after completion of study treatment ]
    Number of participants with adverse event

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. Pharmacokinetics- Cmax [ Time Frame: Up to 3 years ]
    Maximum plasma concentration of drug

  7. Pharmacokinetics- Tmax [ Time Frame: Up to 3 years ]
    Time to peak (maximum) serum concentration

  8. Pharmacokinetics- AUC(TAU) [ Time Frame: Up to 3 years ]
    Area under the serum concentration time-curve

  9. Pharmacokinetics- CLT [ Time Frame: Up to 3 years ]
    Total body clearance of the drug from the serum

  10. Pharmacokinetics- Ctrough [ Time Frame: Up to 3 years ]
    Lowest concentration of drug immediately prior to administration of the next dose

  11. Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection [ Time Frame: Up to 3 years ]
    Anti-CC-99712 antibodies


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participants must satisfy the following criteria to be enrolled in the study:

Inclusion

  • 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.

Exclusion Criteria

  • 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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04036461    
Other Study ID Numbers: CC-99712-MM-001
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
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Multiple Myeloma
Relapsed and refractory
CC-99712
 BCMA
Antibody drug conjugate
BMS-986405
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Gamma Secretase Inhibitors and Modulators
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action