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

NCT ID: NCT04036461

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2024-08-19

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 (CC-99712 monotherapy)

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

Group Type EXPERIMENTAL

CC-99712

Intervention Type DRUG

CC-99712

Arm 2 (CC-99712 and BMS-986405 combination)

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

Group Type EXPERIMENTAL

CC-99712

Intervention Type DRUG

CC-99712

BMS-986405

Intervention Type DRUG

BMS-986405

Interventions

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CC-99712

CC-99712

Intervention Type DRUG

BMS-986405

BMS-986405

Intervention Type DRUG

Other Intervention Names

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GSI (Gamma secretase inhibitor)

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 107

La Jolla, California, United States

Site Status

Local Institution - 105

Sarasota, Florida, United States

Site Status

Local Institution - 103

Buffalo, New York, United States

Site Status

Local Institution - 106

New York, New York, United States

Site Status

Local Institution - 101

Portland, Oregon, United States

Site Status

Local Institution - 104

Dallas, Texas, United States

Site Status

Local Institution - 102

Seattle, Washington, United States

Site Status

Local Institution - 202

Toronto, Ontario, Canada

Site Status

Local Institution - 201

Montreal, Quebec, Canada

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

CHU Montpellier - Hôpital Saint Eloi

Montpellier, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Local Institution - 305

Pierre-Bénite, , France

Site Status

Local Institution - 501

Bologna, , Italy

Site Status

Local Institution - 405

Barcelona, , Spain

Site Status

Local Institution - 401

Madrid, , Spain

Site Status

Local Institution - 0505

Málaga, , Spain

Site Status

Local Institution - 402

Salamanca, , Spain

Site Status

Local Institution - 404

Sevillla, , Spain

Site Status

Local Institution - 403

Valencia, , Spain

Site Status

Countries

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United States Canada France Italy Spain

Related Links

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Other Identifiers

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U1111-1231-9404

Identifier Type: OTHER

Identifier Source: secondary_id

2020-004514-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-99712-MM-001

Identifier Type: -

Identifier Source: org_study_id

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