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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036461
• Other study ID #: CC-99712-MM-001
• Secondary ID: U1111-1231-94042
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 26, 2019
• Est. completion date: August 23, 2024

Study information

• Verified date: January 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: August 23, 2024
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CC-99712
CC-99712
• BMS-986405
BMS-986405

Locations

Country	Name	City	State
Canada	Local Institution - 201	Montreal	Quebec
Canada	Local Institution - 202	Toronto	Ontario
France	Institut Paoli Calmettes	Marseille Cedex 9
France	CHU Montpellier - Hôpital Saint Eloi	Montpellier CEDEX 5
France	Hopital Saint Antoine	Paris
France	Local Institution - 305	Pierre Bénite
Italy	Local Institution - 501	Bologna
Spain	Local Institution - 405	Barcelona
Spain	Local Institution - 401	Madrid
Spain	Local Institution - 0505	Malaga
Spain	Local Institution - 402	Salamanca
Spain	Local Institution - 404	Sevillla
Spain	Local Institution - 403	Valencia
United States	Local Institution - 103	Buffalo	New York
United States	Local Institution - 104	Dallas	Texas
United States	Local Institution - 107	La Jolla	California
United States	Local Institution - 106	New York	New York
United States	Local Institution - 101	Portland	Oregon
United States	Local Institution - 105	Sarasota	Florida
United States	Local Institution - 102	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)	Number of participants with adverse event	From enrollment until at least 42 days after completion of study treatment
Primary	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
Primary	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	Overall Response Rate (ORR)	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.	Up to 3 years
Secondary	Time to Response	Is defined as the time from the first CC-99712 dose date to the date of first documented response (PR or better).	Up to 3 years
Secondary	Duration of Response	Is defined as the time from the earliest date of documented response (= PR) to the first documented disease progression or death, whichever occurs first.	Up to 3 years
Secondary	Progression-free Survival (PFS)	Is defined as the time from the first dose of CC-99712 to progressive disease (PD) or death from any cause, whichever occurs first.	Up to 3 years
Secondary	Overall Survival (OS)	Is defined as the time from the first dose of CC-99712 to death from any cause.	Up to 3 years
Secondary	Pharmacokinetics- Cmax	Maximum plasma concentration of drug	Up to 3 years
Secondary	Pharmacokinetics- Tmax	Time to peak (maximum) serum concentration	Up to 3 years
Secondary	Pharmacokinetics- AUC(TAU)	Area under the serum concentration time-curve	Up to 3 years
Secondary	Pharmacokinetics- CLT	Total body clearance of the drug from the serum	Up to 3 years
Secondary	Pharmacokinetics- Ctrough	Lowest concentration of drug immediately prior to administration of the next dose	Up to 3 years
Secondary	Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection	Anti-CC-99712 antibodies	Up to 3 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting