Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04975399
• Other study ID #: CC-92328-MM-001
• Secondary ID: 2020-005968-64
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 5, 2021
• Est. completion date: June 21, 2026

Study information

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

Clinical Trial Summary

This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). The study will be conducted in two parts: monotherapy dose escalation (Part A) and monotherapy dose expansion (Part B).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 21, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

1. must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.

2. willing and able to adhere to the study visit schedule and other protocol requirements.

3. Participant is = 18 years of age the time of signing the ICF.

4. Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit.

5. Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.

6. Participant must have measurable disease.

7. Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

8. Females of childbearing potential (FCBP) must commit to true abstinence from heterosexual contact or agree to use at least one method of highly effective contraception without interruption from screening to at least 12 weeks after the last dose of CC-92328

9. Males must practice true abstinence or agree to use a condom

10. FCBP and males must avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of CC-92328.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

1. Participant has symptomatic central nervous system involvement of MM.

2. Participant had a prior autologous stem cell transplant = 90 days prior to starting CC-92328.

3. Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning = 12 months prior to starting CC-92328.

4. Participant had prior systemic cancer-directed treatments or investigational modalities = 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.

5. Participant is a pregnant or lactating female.

6. Participant received live virus vaccines within at least 4 weeks prior to starting study drug.

7. Participant has known active human immunodeficiency virus (HIV) infection.

8. Participant has active hepatitis B or C (HBV/HCV) infection.

9. Participant weight is = 40 kg at screening.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CC-92328
CC-92328

Locations

Country	Name	City	State
Canada	Local Institution - 201	Calgary	Alberta
Canada	Local Institution - 204	Edmonton	Alberta
Canada	Local Institution - 203	Halifax	Nova Scotia
Canada	Local Institution - 205	Montreal	Quebec
Canada	Local Institution - 202	Toronto	Ontario
Spain	Local Institution - 301	Badalona
Spain	Local Institution - 302	Pamplona	Navarra
Spain	Local Institution - 303	Salamanca
Spain	Local Institution - 304	Santander
United States	Local Institution - 104	Birmingham	Alabama
United States	Local Institution - 101	Milwaukee	Wisconsin
United States	Local Institution - 107	New York	New York
United States	Local Institution - 108	New York	New York
United States	Local Institution - 105	Scottsdale	Arizona
United States	Local Institution - 106	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicities (DLTs)	Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to the underlying disease or extraneous causes.	Up to 28 days after the first dose
Primary	Maximum Tolerated Dose (MTD)	Defined as the highest dose at which less than 33% of the population treated with CC-92328 experience a dose-limiting toxicity (DLT) in the first cycle and at least 6 evaluable participants have been treated at this dose level.	Up to 12 weeks after the last dose
Primary	Incidence of Adverse Events (AEs)	Type, frequency, seriousness, severity and relationship of AEs to CC-92328.	Up to 12 weeks after the last dose
Secondary	Preliminary Efficacy - Overall Response Rate (ORR)	Defined as the proportion of participants who achieve a partial response (PR) or better according to IMWG response criteria.	Up to approximately 2 years
Secondary	Preliminary Efficacy - Time to response	Defined as the time from the first CC-92328 dose date to the date of first documented response (PR or better).	Up to approximately 2 years
Secondary	Preliminary Efficacy - Duration of response	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 approximately 2 years
Secondary	Preliminary Efficacy - Progression-free Survival (PFS)	Defined as the time from the first dose of CC-92328 to pharmacodynamics (PD) or death from any cause, whichever occurs first.	Up to approximately 2 years
Secondary	Preliminary Efficacy - Overall Survival (OS)	Defined as the time from the first dose of CC-92328 to death from any cause.	Up to approximately 2 years
Secondary	Pharmacokinetics - Cmax	Maximum serum concentration of drug.	Day 1 to 9 weeks after last dose of study drug
Secondary	Pharmacokinetics - Cmin	Minimum serum concentration of drug.	Day 1 to 9 weeks after last dose of study drug
Secondary	Pharmacokinetics - AUC	Area under the curve.	Day 1 to 9 weeks after last dose of study drug
Secondary	Pharmacokinetics - tmax	Time to peak (maximum) serum concentration.	Day 1 to 9 weeks after last dose of study drug
Secondary	Pharmacokinetics - t1/2	Half-life.	Day 1 to 9 weeks after last dose of study drug
Secondary	Pharmacokinetics - CL	Total body clearance of the drug from the serum.	Day 1 to 9 weeks after last dose of study drug
Secondary	Pharmacokinetics - Vd	Volume of distribution.	Day 1 to 9 weeks after last dose of study drug
Secondary	Pharmacokinetics - Accumulation index of CC-92328	Calculated from the serum concentration-time data of CC-92328 using non-compartment methods.	Day 1 to 9 weeks after last dose of study drug
Secondary	Presence of Anti-CC92328 antibodies (ADA)	Determined using a validated bridging immunoassay with electrochemiluminescence detection.	Day 1 to 9 weeks after last dose of study drug
Secondary	Frequency of Anti-CC92328 antibodies (ADA)	Determined using a validated bridging immunoassay with electrochemiluminescence detection.	Day 1 to 9 weeks after last dose of study drug

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting