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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
Documented disease progression on or within 60 days from the last dose of their last myeloma therapy.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My myeloma worsened within 2 months after my last treatment.
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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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My last treatment for myeloma was CAR-T therapy, and my disease has progressed since.
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I am following the required pregnancy prevention measures.
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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 agree not to donate blood while on CC-92480 and for 28 days after stopping it.
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I have been diagnosed with multiple myeloma and it can be measured.

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

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

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

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
CC-92480
2018
Completed Phase 1
~150
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
632 Previous Clinical Trials
127,719 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,662 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,499 Previous Clinical Trials
3,367,341 Total Patients Enrolled
71 Trials studying Multiple Myeloma
25,036 Patients Enrolled for Multiple Myeloma
David Yao, MD, PhDStudy DirectorBristol-Myers Squibb

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this trial still open?

"As per clinicaltrials.gov, this research endeavour is actively recruiting participants. The trial was initialy advertised on February 6th 2018 and underwent a recent update on October 25th 2022."

Answered by AI

To what ailments does CC-92480 most commonly provide therapeutic relief?

"CC-92480 is mostly employed to treat ophthalmia, sympathetic. Additionally, it has been observed that this pharmaceutical can have a beneficial effect on conditions like branch retinal vein occlusion and macular edema."

Answered by AI

Could you enumerate the research undertaken regarding CC-92480?

"The initial research into CC-92480 took place back in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, 1111 trials have been completed, and there are currently 552 ongoing studies; many of these being conducted out of New york City."

Answered by AI

What are the major goals for this clinical exploration?

"This 28-day trial seeks to evaluate the pharmacokinetic half-life of an investigational drug. Secondary analysis will consider time from first response (≥ PR) until progression or death, time from the initial dose to a partial response and overall response rate according to IMWG Uniform Response Criteria."

Answered by AI

How many research centers are currently implementing this trial?

"Memorial Sloan Kettering Cancer Center in New york, Roswell Park in Buffalo and University Of Virginia in Charlottesville are amongst the 25 recruiting centres for this clinical trial. The other locations have similarly been selected to ensure a wide range of patient participation."

Answered by AI

What is the total enrollment number for this experimental research?

"Affirmative. Clinicaltrials.gov has records of this trial being initiated on February 6th 2018 and recently updated on October 25th 2022, presently looking for 201 participants at twenty-five locations."

Answered by AI
~15 spots leftby Oct 2024