← Back to Search

Proteasome Inhibitor

CC-92480 + Standard Treatments for Multiple Myeloma

Phase 1 & 2

Recruiting

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

For participants in Cohorts A, B, C, D, E, F, H, I, J, and K: documented diagnosis of multiple myeloma (MM) and measurable disease, documented disease progression during or after their last antimyeloma regimen, achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective when used with standard treatments.

Who is the study for?

This trial is for adults with Multiple Myeloma who've seen their cancer grow despite treatment and responded at least once to prior therapy. They should be fairly active and able to care for themselves (ECOG score of 0-2). People can't join if they have myeloma in the brain, took strong immune drugs recently, or have certain other blood disorders or uncontrolled conditions like high blood pressure.Check my eligibility

What is being tested?

The study tests CC-92480 combined with standard myeloma treatments (like Isatuximab, Bortezomib) to see how safe it is and if it works against cancer that's come back or didn't respond well before. Participants will receive different combinations based on which group they're assigned to.See study design

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, nerve damage causing pain or numbness, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I have multiple myeloma with measurable disease and it has worsened after treatment but I responded to at least one prior treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 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

Number of participants with Adverse Events (AEs)

Overall response rate (ORR)

Recommended Dose

+1 more

Secondary outcome measures

Complete Response (CR) rate

Duration of response (DOR)

Time-to-response (TTR)

+1 more

Trial Design

15Treatment groups

Experimental Treatment

Group I: Subcohort E3: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group II: Subcohort E2: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight, administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards

Group III: Subcohort E1: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 28-day cycle Either IV DARA administered at a dose of 16 mg/kg or SC DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group IV: Subcohort B3: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort B dose administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group V: Subcohort B2: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort dose administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight, administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards

Group VI: Subcohort B1: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort dose administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group VII: Cohort K: CC-92480 with isatuximab and dexamethasoneExperimental Treatment3 Interventions

Group VIII: Cohort J: CC-92480 with elotuzumab and dexamethasoneExperimental Treatment3 Interventions

Group IX: Cohort I: CC-92480 with isatuximab and dexamethasoneExperimental Treatment3 Interventions

Group X: Cohort H: CC-92480 with elotuzumab and dexamethasoneExperimental Treatment3 Interventions

Group XI: Cohort G: CC-92480 with bortezomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle up to Cycle 6 Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle up to Cycle 6

Group XII: Cohort F: CC-92480 with carfilzomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 28-day cycle Intravenous (IV) carfilzomib 20 mg/m2 then 56 mg/m2 administered over a 28-day cycle Oral/IV dexamethasone 40 mg/day (20 mg/day for subjects > 75 years old) administered over a 28-day cycle

Group XIII: Cohort D: CC-92480 with bortezomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle in the first 8 cycles and on days 1, 2, 8 and 9 after Cycle 8

Group XIV: Cohort C: CC-92480 with carfilzomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort C dose administered over a 28-day cycle Intravenous (IV) carfilzomib 20 mg/m2 then 56 mg/m2 administered over a 28-day cycle Oral/IV dexamethasone 40 mg/day (20 mg/day for subjects > 75 years old) administered over a 28-day cycle

Group XV: Cohort A: CC-92480 with bortezomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort A dose administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle in the first 8 cycles and on days 1, 2, 8 and 9 after Cycle 8

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-92480

2018

Completed Phase 1

~150

Isatuximab

2016

Completed Phase 3

~370

Bortezomib

2005

Completed Phase 2

~1140

Dexamethasone

2007

Completed Phase 4

~2590

Daratumumab

2014

Completed Phase 3

~1860

Carfilzomib

2017

Completed Phase 3

~1440

Elotuzumab

2016

Completed Phase 3

~800

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,430 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,439 Patients Enrolled for Multiple Myeloma

Alessandro Ghiddi, MDStudy DirectorCelgene

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,507 Previous Clinical Trials

3,369,399 Total Patients Enrolled

72 Trials studying Multiple Myeloma

24,863 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03989414 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Cohort G: CC-92480 with bortezomib and dexamethasone, Cohort D: CC-92480 with bortezomib and dexamethasone, Cohort F: CC-92480 with carfilzomib and dexamethasone, Subcohort B2: CC-92480 with daratumumab and dexamethasone, Cohort J: CC-92480 with elotuzumab and dexamethasone, Subcohort E2: CC-92480 with daratumumab and dexamethasone, Cohort K: CC-92480 with isatuximab and dexamethasone, Subcohort B3: CC-92480 with daratumumab and dexamethasone, Subcohort E1: CC-92480 with daratumumab and dexamethasone, Subcohort B1: CC-92480 with daratumumab and dexamethasone, Subcohort E3: CC-92480 with daratumumab and dexamethasone, Cohort A: CC-92480 with bortezomib and dexamethasone, Cohort C: CC-92480 with carfilzomib and dexamethasone, Cohort H: CC-92480 with elotuzumab and dexamethasone, Cohort I: CC-92480 with isatuximab and dexamethasone

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT03989414 — Phase 1 & 2

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03989414 — 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 this experiment currently accepting new participants?

"According to the clinicaltrials.gov database, this research effort is currently in search of volunteers for its study. The trial was initially posted on September 30th 2019 and has been recently updated on November 17th 2022."

Answered by AI

To what conditions is CC-92480 typically prescribed?

"CC-92480 is regularly used to manage ophthalmia, sympathetic and it has been found effective in treating branch retinal vein occlusion, macular edema, communicable diseases."

Answered by AI

What is the aggregate size of the patient population engaged in this clinical experiment?

"This clinical trial requires 384 patients to meet enrollment expectations, all of whom must adhere to the inclusion requirements. These individuals can receive treatment from locations such as Dana-Farber/Mass General Brigham Cancer Care in Boston and H. Lee Moffitt Cancer Center & Research Institute down in Tampa Bay."

Answered by AI

Are there any extant investigations concerning CC-92480?

"At present, 674 medical trials are in progress to research the potential of CC-92480. Out of these studies, 152 have reached Phase 3. Although Joliet, Illinois is home to most studies concerning this drug, there are 21858 locations globally conducting experiments with it."

Answered by AI

How many facilities are overseeing this clinical trial?

"The clinical study is being conducted at 23 sites, including Dana-Farber/Mass General Brigham Cancer Care in Boston and H. Lee Moffitt Cancer Center & Research Institute in Tampa; the list of participating institutions also contains Local Institution - 202 located in Montreal plus another 20 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

2019. "A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03989414.

All > Velcade