Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT04975399 Recruiting July 23, 2021 February 7, 2022

study description
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: Multiple Myeloma
Intervention/treatment: Drug: CC-92328
Phase: Phase 1
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 70 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date: October 2021
Estimated Primary Completion Date: February 2026
Estimated Study Completion Date: February 2026

Arms and interventions
Arm Intervention/treatment
Experimental: Administration of CC-92328
CC-92328 administered intravenously in 28-day cycles
Drug: CC-92328
CC-92328
outcome measures
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.

Eligibility Criteria
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:

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 9 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 9 weeks after the last dose of CC-92328.

Exclusion Criteria:

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.


Contacts and Locations
Contacts

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
United States, Alabama University of Alabama at Birmingham Hospital Birmingham
United States, Arizona HonorHealth Research Institute Scottsdale
United States, Florida University of South Florida (USF) Tampa
United States, Maryland Johns Hopkins Oncology Center Baltimore
United States, New York Memorial Sloan-Kettering Cancer Center - David H. Koch Center for Cancer Care New York
United States, New York Mt. Sinai Medical Center Division of Hematology/Oncology New York
United States, Wisconsin Froedtert Hospital BMT Medical College of Wisconsin Milwaukee
Canada, Alberta Tom Baker Cancer Center Calgary
Canada, Alberta Cross Cancer Institute Edmonton
Canada, Nova Scotia Dalhousie University Halifax
Canada, Ontario Princess Margaret Hospital University Health Network Toronto
Canada, Quebec McGill University Health Center (MUHC) Montreal
Spain Hospital Germans Trias I Pujol Badalona
Spain Clinica Universidad de Navarra Pamplona
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universtario Marques de Valdecilla Santander
Sweden Sahlgrenska Universitetssjukhus Göteborg
Sponsors and Collaborators
Celgene
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT04975399     
Other Study ID Numbers : CC-92328-MM-001, 2020-005968-64
First Posted : July 23, 2021
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/
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 :
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