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Anti-cancer agent

CC-92480 + Dexamethasone for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Male subjects must meet specific contraception requirements.
Must not have
Subject has a history of allogeneic bone marrow transplantation within specific timeframes.
Subjects with peripheral neuropathy ≥ Grade 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat Multiple Myeloma that has relapsed or become refractory to other treatments. The trial will assess the safety and efficacy of the new treatment.

Who is the study for?
This trial is for adults over 18 with relapsed and refractory multiple myeloma who've had at least 3 prior treatments, including specific medications, and are not responding to their last therapy. They must have measurable disease, meet certain lab value criteria, be able to follow the study plan, and use contraception if of childbearing potential.
What is being tested?
The trial is testing CC-92480 alone and combined with Dexamethasone in patients whose multiple myeloma has returned or resisted treatment. It's an open-label Phase 1/2 study assessing safety, how the body processes the drug (PK), and its effectiveness against this cancer.
What are the potential side effects?
Potential side effects include typical reactions related to immune system suppression such as increased infection risk, possible blood disorders or changes in blood pressure/sugar levels due to dexamethasone, fatigue, gastrointestinal issues like nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I am following the required contraception guidelines.
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I am 18 years or older and can sign the consent form.
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My condition hasn't improved after taking certain medications.
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I have undergone 3 or more treatments for myeloma, including specific medications.
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I have been diagnosed with multiple myeloma and it can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bone marrow transplant from another person.
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I have moderate to severe nerve damage.
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I had major surgery recently.
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I have heart problems that affect my daily activities.
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I have been diagnosed with amyloidosis or POEMS Syndrome.
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I am currently receiving treatment for another type of cancer.
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I have an active chronic hepatitis B or C infection.
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I have been treated for myeloma with specific drugs recently.
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I cannot or do not want to follow the required blood clot prevention treatment.
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My multiple myeloma does not produce detectable levels of M protein.
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I am HIV positive.
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My multiple myeloma has not responded to treatment.
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I have IgM myeloma.
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I have plasma cell leukemia or active leptomeningeal myelomatosis.
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I am currently receiving dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD)
Overall Response Rate (ORR)
Pharmacokinetics- AUC
+5 more
Secondary study objectives
Adverse Events (AEs)
Duration of response (DOR)
Overall response rate (ORR)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Administration of CC-92480 monotherapyExperimental Treatment1 Intervention
Escalating doses of CC-92480 Monotherapy administered according to different dosing schedules
Group II: Administration of CC-92480 in combination with dexamethasoneExperimental Treatment2 Interventions
Part 1: Escalating doses of CC-92480 plus a fixed dose of dexamethasone Part 2: RP2D of CC-92480 in combination with dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
CC-92480
2018
Completed Phase 1
~150

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
129,983 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,605 Patients Enrolled for Multiple Myeloma
David Yao, MD, PhDStudy DirectorBristol-Myers Squibb
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,485 Total Patients Enrolled
77 Trials studying Multiple Myeloma
28,918 Patients Enrolled for Multiple Myeloma

Media Library

CC-92480 (Anti-cancer agent) Clinical Trial Eligibility Overview. Trial Name: NCT03374085 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Administration of CC-92480 in combination with dexamethasone, Administration of CC-92480 monotherapy
Multiple Myeloma Clinical Trial 2023: CC-92480 Highlights & Side Effects. Trial Name: NCT03374085 — Phase 1 & 2
CC-92480 (Anti-cancer agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03374085 — Phase 1 & 2
~22 spots leftby Nov 2025
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