Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma
NCT ID: NCT04975399
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
26 participants
INTERVENTIONAL
2021-10-05
2024-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of CC-92328
CC-92328 administered intravenously in 28-day cycles
CC-92328
CC-92328
Interventions
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CC-92328
CC-92328
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 104
Birmingham, Alabama, United States
Local Institution - 105
Scottsdale, Arizona, United States
Local Institution - 106
Tampa, Florida, United States
Local Institution - 108
New York, New York, United States
Local Institution - 107
New York, New York, United States
Local Institution - 101
Milwaukee, Wisconsin, United States
Local Institution - 201
Calgary, Alberta, Canada
Local Institution - 204
Edmonton, Alberta, Canada
Local Institution - 203
Halifax, Nova Scotia, Canada
Local Institution - 202
Toronto, Ontario, Canada
Local Institution - 205
Montreal, Quebec, Canada
Local Institution - 302
Pamplona, Navarre, Spain
Local Institution - 301
Badalona, , Spain
Local Institution - 303
Salamanca, , Spain
Local Institution - 304
Santander, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-005968-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-92328-MM-001
Identifier Type: -
Identifier Source: org_study_id
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