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

NCT04975399 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CC-92328-MM-0012020-005968-64
• Study Type: interventional
• Target: 26
• Locations: 3 countries
• Sites: 15

Brief 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).

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; First-in-human; Phase 1; Relapsed or Refractory; CC-92328

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• Preliminary Efficacy - Overall Response Rate (ORR)

  Up to approximately 2 years

• Preliminary Efficacy - Time to response

  Up to approximately 2 years

• Preliminary Efficacy - Duration of response

  Up to approximately 2 years

• Preliminary Efficacy - Progression-free Survival (PFS)

  Up to approximately 2 years

• Preliminary Efficacy - Overall Survival (OS)

  Up to approximately 2 years

Study Arms (1)

Administration of CC-92328

EXPERIMENTAL

CC-92328 administered intravenously in 28-day cycles

Drug: CC-92328

Interventions

CC-92328 DRUG

CC-92328

Administration of CC-92328

Eligibility Criteria

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

You may qualify if:

• Participants must satisfy the following criteria to be enrolled in the study:
• must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
• willing and able to adhere to the study visit schedule and other protocol requirements.
• Participant is ≥ 18 years of age the time of signing the ICF.
• 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.
• Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.
• Participant must have measurable disease.
• Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• 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
• Males must practice true abstinence or agree to use a condom
• 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.

You may not qualify if:

• The presence of any of the following will exclude a participant from enrollment:
• Participant has symptomatic central nervous system involvement of MM.
• Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-92328.
• Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting CC-92328.
• Participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
• Participant is a pregnant or lactating female.
• Participant received live virus vaccines within at least 4 weeks prior to starting study drug.
• Participant has known active human immunodeficiency virus (HIV) infection.
• Participant has active hepatitis B or C (HBV/HCV) infection.
• Participant weight is ≤ 40 kg at screening.

Sponsors & Collaborators

• Celgene: lead

Study Sites (15)

Local Institution - 104

Birmingham, Alabama, 35233, United States

Location

Local Institution - 105

Scottsdale, Arizona, 85258, United States

Location

Local Institution - 106

Tampa, Florida, 33612, United States

Location

Local Institution - 108

New York, New York, 10021, United States

Location

Local Institution - 107

New York, New York, 10029, United States

Location

Local Institution - 101

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 201

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 204

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 203

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution - 202

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 205

Montreal, Quebec, H4A3J1, Canada

Location

Local Institution - 302

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 301

Badalona, 8916, Spain

Location

Local Institution - 303

Salamanca, 37007, Spain

Location

Local Institution - 304

Santander, 39008, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: October 5, 2021
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

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

ES (4); US (6); CA (5)