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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04975399
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-92328 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : February 10, 2026
Estimated Study Completion Date : February 10, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Administration of CC-92328
CC-92328 administered intravenously in 28-day cycles
Drug: CC-92328
CC-92328




Primary Outcome Measures :
  1. 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.

  2. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 9 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.

  3. Incidence of Adverse Events (AEs) [ Time Frame: Up to 9 weeks after the last dose ]
    Type, frequency, seriousness, severity and relationship of AEs to CC-92328.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. Pharmacokinetics - Cmax [ Time Frame: Day 1 to 9 weeks after last dose of study drug ]
    Maximum serum concentration of drug.

  7. Pharmacokinetics - Cmin [ Time Frame: Day 1 to 9 weeks after last dose of study drug ]
    Minimum serum concentration of drug.

  8. Pharmacokinetics - AUC [ Time Frame: Day 1 to 9 weeks after last dose of study drug ]
    Area under the curve.

  9. Pharmacokinetics - tmax [ Time Frame: Day 1 to 9 weeks after last dose of study drug ]
    Time to peak (maximum) serum concentration.

  10. Pharmacokinetics - t1/2 [ Time Frame: Day 1 to 9 weeks after last dose of study drug ]
    Half-life.

  11. Pharmacokinetics - CL [ Time Frame: Day 1 to 9 weeks after last dose of study drug ]
    Total body clearance of the drug from the serum.

  12. Pharmacokinetics - Vd [ Time Frame: Day 1 to 9 weeks after last dose of study drug ]
    Volume of distribution.

  13. 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.

  14. 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.

  15. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 9 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 9 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975399


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 17 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04975399    
Other Study ID Numbers: CC-92328-MM-001
2020-005968-64 ( EudraCT Number )
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Multiple Myeloma
First-in-human
Phase 1
Relapsed or Refractory
CC-92328
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases