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

NCT04036461 | Terminated Phase 1 FDA Drug

• 3 other identifiers: CC-99712-MM-001U1111-1231-94042020-004514-35
• Study Type: interventional
• Target: 47
• Locations: 5 countries
• Sites: 20

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Relapsed and refractory; CC-99712; BCMA; Antibody drug conjugate; BMS-986405

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AEs)

  Number of participants with adverse event

  From enrollment until at least 42 days after completion of study treatment

• Maximum Tolerated Dose (MTD) in participants with relapsed and refractory MM

  Is defined as the highest dose that causes DLTs in no more than 33% of patient population during the first cycle of treatment.

  Up to 28 days

• Dose Limiting Toxicity (DLT) in participants with relapsed and refractory MM

  Is defined as any of the following toxicities occurring within the DLT assessment window

  Up to 28 days

Secondary Outcomes (11)

• Overall Response Rate (ORR)

  Up to 3 years

• Time to Response

  Up to 3 years

• Duration of Response

  Up to 3 years

• Progression-free Survival (PFS)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

Study Arms (2)

Arm 1 (CC-99712 monotherapy)

EXPERIMENTAL

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

Drug: CC-99712

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

EXPERIMENTAL

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

Drug: CC-99712; Drug: BMS-986405

Interventions

CC-99712 DRUG

CC-99712

Arm 1 (CC-99712 monotherapy); Arm 2 (CC-99712 and BMS-986405 combination)

BMS-986405 DRUG

BMS-986405

Also known as: GSI (Gamma secretase inhibitor)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (20)

Local Institution - 107

La Jolla, California, 92093, United States

Location

Local Institution - 105

Sarasota, Florida, 34232, United States

Location

Local Institution - 103

Buffalo, New York, 14263, United States

Location

Local Institution - 106

New York, New York, 10029, United States

Location

Local Institution - 101

Portland, Oregon, 97239, United States

Location

Local Institution - 104

Dallas, Texas, 75390, United States

Location

Local Institution - 102

Seattle, Washington, 98104, United States

Location

Local Institution - 202

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 201

Montreal, Quebec, H1T 2M4, Canada

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU Montpellier - Hôpital Saint Eloi

Montpellier, 34295, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Local Institution - 305

Pierre-Bénite, 69495, France

Location

Local Institution - 501

Bologna, 40138, Italy

Location

Local Institution - 405

Barcelona, 08036, Spain

Location

Local Institution - 401

Madrid, 28041, Spain

Location

Local Institution - 0505

Málaga, 29010, Spain

Location

Local Institution - 402

Salamanca, 37007, Spain

Location

Local Institution - 404

Sevillla, 41013, Spain

Location

Local Institution - 403

Valencia, 46026, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: August 26, 2019
• Primary Completion: July 8, 2024
• Study Completion: August 19, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (7); ES (6); CA (2); IT (1); FR (4)