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

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

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).

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: CC-92328

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Local Institution - 201
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 204
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Local Institution - 203
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 202
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • Local Institution - 205
• Spain
  • Badalona, Spain, 8916
    • Local Institution - 301
  • Salamanca, Spain, 37007
    • Local Institution - 303
  • Santander, Spain, 39008
    • Local Institution - 304
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Local Institution - 302
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Local Institution - 104
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Local Institution - 105
  • Florida
    • Tampa, Florida, United States, 33612
      • Local Institution - 106
  • New York
    • New York, New York, United States, 10021
      • Local Institution - 108
    • New York, New York, United States, 10029
      • Local Institution - 107
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Local Institution - 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of CC-92328; CC-92328 administered intravenously in 28-day cycles	Drug: CC-92328; CC-92328

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Pharmacokinetics - Cmax	Maximum serum concentration of drug.	Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Cmin	Minimum serum concentration of drug.	Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - AUC	Area under the curve.	Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - tmax	Time to peak (maximum) serum concentration.	Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - t1/2	Half-life.	Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - CL	Total body clearance of the drug from the serum.	Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Vd	Volume of distribution.	Day 1 to 9 weeks after last dose of study drug
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
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
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

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): June 18, 2024
• Study Completion (Actual): June 18, 2024

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Phase 1; Relapsed or Refractory; First-in-human; CC-92328
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CC-92328-MM-001; 2020-005968-64 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No