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

March 19, 2025 updated by: Celgene

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 28 days after the first dose
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)
Time Frame: Up to 12 weeks after the last dose
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)
Time Frame: Up to 12 weeks after the last dose
Type, frequency, seriousness, severity and relationship of AEs to CC-92328.
Up to 12 weeks after the last dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preliminary Efficacy - Overall Response Rate (ORR)
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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)
Time Frame: Up to approximately 2 years
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)
Time Frame: Up to approximately 2 years
Defined as the time from the first dose of CC-92328 to death from any cause.
Up to approximately 2 years
Pharmacokinetics - Cmax
Time Frame: Day 1 to 9 weeks after last dose of study drug
Maximum serum concentration of drug.
Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Cmin
Time Frame: Day 1 to 9 weeks after last dose of study drug
Minimum serum concentration of drug.
Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - AUC
Time Frame: Day 1 to 9 weeks after last dose of study drug
Area under the curve.
Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - tmax
Time Frame: Day 1 to 9 weeks after last dose of study drug
Time to peak (maximum) serum concentration.
Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - t1/2
Time Frame: Day 1 to 9 weeks after last dose of study drug
Half-life.
Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - CL
Time Frame: Day 1 to 9 weeks after last dose of study drug
Total body clearance of the drug from the serum.
Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Vd
Time Frame: Day 1 to 9 weeks after last dose of study drug
Volume of distribution.
Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Accumulation index of CC-92328
Time Frame: Day 1 to 9 weeks after last dose of study drug
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)
Time Frame: Day 1 to 9 weeks after last dose of study drug
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)
Time Frame: Day 1 to 9 weeks after last dose of study drug
Determined using a validated bridging immunoassay with electrochemiluminescence detection.
Day 1 to 9 weeks after last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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