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

NCT03989414

Description:

This is an open-label, multicenter, Phase 1/2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Determine the Recommended Dose and Regimen and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
  • Official Title: A Phase 1/2 Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Clinical Trial IDs

  • ORG STUDY ID: CC-92480-MM-002
  • SECONDARY ID: U1111-1233-5619
  • SECONDARY ID: 2018-004767-31
  • NCT ID: NCT03989414

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CC-92480CC-92480 in combination with bortezomib and dexamethasone
BortezomibCC-92480 in combination with bortezomib and dexamethasone
DexamethasoneCC-92480 in combination with bortezomib and dexamethasone
DaratumumabCC-92480 in combination with daratumumab and dexamethasone
CarfilzomibCC-92480 in combination with carfilzomib and dexamethasone

Purpose

This is an open-label, multicenter, Phase 1/2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Trial Arms

NameTypeDescriptionInterventions
CC-92480 in combination with bortezomib and dexamethasoneExperimentalSubjects in cohorts A, D and G will receive following: Oral CC-92480 at specified cohort 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) administered over a 21-day cycle
  • CC-92480
  • Bortezomib
  • Dexamethasone
CC-92480 in combination with daratumumab and dexamethasoneExperimentalSubjects in cohorts B and E will receive following: Oral CC-92480 at specified cohort dose administered over a 28-day cycle Intravenous (IV) daratumumab 16 mg/kg administered over a 28-day cycle Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle
  • CC-92480
  • Dexamethasone
  • Daratumumab
CC-92480 in combination with carfilzomib and dexamethasoneExperimentalSubjects in cohort C and F will receive following: Oral CC-92480 at specified cohort 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
  • CC-92480
  • Dexamethasone
  • Carfilzomib

Eligibility Criteria

        Inclusion Criteria:

          1. Subjects is ≥ 18 years of age and has an Eastern Cooperative Oncology Group (ECOG)
             performance status score of 0, 1 or 2.

          2. Relapsed or refractory subjects must have measurable disease and have documented
             disease progression during or after their last anti-myeloma regimen.

          3. Newly diagnosed subjects must have documented diagnosis with previously untreated
             symptomatic multiple myeloma.

          4. Females of childbearing potential (FCBP) and male subjects must agree with the
             pregnancy prevention plan.

        Exclusion Criteria:

          1. Subject has a significant medical condition, laboratory abnormality, or psychiatric
             illness that would prevent the subject from participating in the study.

          2. Subject is unable or unwilling to undergo protocol required thromboembolism
             prophylaxis.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting Toxicities (DLT)
Time Frame:UP to approximately 2 years from enrollment
Safety Issue:
Description:Number of participants with DLTs in the first cycle of the treatment

Secondary Outcome Measures

Measure:Time-to-response (TTR)
Time Frame:UP to approximately 3 years from enrollment
Safety Issue:
Description:Time from first dose to the first documentation of response (PR or greater)
Measure:Duration of response (DOR)
Time Frame:Up to approximately 3 years from enrollment
Safety Issue:
Description:Time from the first documentation of response (PR or greater) to the first documentation of progressive disease (PD) or death
Measure:Complete Response (CR) rate
Time Frame:Up to approximately 3 years from enrollment
Safety Issue:
Description:Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria
Measure:Very good partial response (VGPR) rate
Time Frame:Up to approximately 3 years from enrollment
Safety Issue:
Description:Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Relapsed or Refractory Multiple Myeloma
  • Newly Diagnosed Multiple Myeloma
  • Multiple Myeloma
  • CC-92480

Last Updated

April 21, 2020