Multiple Myeloma Clinical Trial

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

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).

View Eligibility Criteria

Eligibility 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 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.

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT04975399

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 18 Locations for this study

See Locations Near You

University of Alabama at Birmingham Hospital
Birmingham Alabama, 35233, United States
University Of Alabama At Birmingham Hospital
Birmingham Alabama, 35233, United States More Info
Susan Bal, Site 104
Contact
205-934-1908
HonorHealth Research Institute
Scottsdale Arizona, 85258, United States
HonorHealth Research Institute
Scottsdale Arizona, 85258, United States More Info
Joseph Mikhael, Site 105
Contact
416-946-2359
University of South Florida (USF)
Tampa Florida, 33612, United States
University of South Florida (USF)
Tampa Florida, 33612, United States More Info
Rachid Baz, Site 106
Contact
813-745-3163
Johns Hopkins Oncology Center
Baltimore Maryland, 21231, United States
Memorial Sloan-Kettering Cancer Center - David H. Koch Center for Cancer Care
New York New York, 10021, United States
Memorial Sloan-Kettering Cancer Center - David H. Koch Center for Cancer Care
New York New York, 10021, United States More Info
Saad Usmani, Site 108
Contact
980-442-2000
Mt. Sinai Medical Center Division of Hematology/Oncology
New York New York, 10029, United States
Mt. Sinai Medical Center Division of Hematology/Oncology
New York New York, 10029, United States More Info
Cesar Rodriguez, Site 107
Contact
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Binod Dhakal, Site 101
Contact
414-805-0638
Tom Baker Cancer Center
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Dalhousie University
Halifax Nova Scotia, B3H 2, Canada
Local Institution - 203
Halifax Nova Scotia, B3H 2, Canada More Info
Site 203
Contact
Local Institution - 202
Toronto Ontario, M5G 2, Canada More Info
Site 202
Contact
Princess Margaret Hospital University Health Network
Toronto Ontario, M5G 2, Canada
McGill University Health Center (MUHC)
Montreal Quebec, H4A 3, Canada
Local Institution - 205
Montreal Quebec, H4A3J, Canada More Info
Site 205
Contact
Hospital Germans Trias I Pujol
Badalona , 8916, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Local Institution - 303
Salamanca , 37007, Spain More Info
Site 303
Contact
Hospital Universtario Marques de Valdecilla
Santander , 39008, Spain
Local Institution - 304
Santander , 39008, Spain More Info
Site 304
Contact
Sahlgrenska Universitetssjukhus
Göteborg , SE-41, Sweden

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT04975399

Recruitment Status:

Recruiting

Sponsor:


Celgene

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