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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/01/2020.

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)

Clinicaltrials.gov identifier NCT03989414

Recruitment Status Recruiting

First Posted June 18, 2019

Last update posted April 24, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-92480
    Drug: Bortezomib
    Drug: Dexamethasone
    Drug: Daratumumab
    Drug: Carfilzomib
  • Phase: Phase 1/Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 215 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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)
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2022
Arms and interventions
Arm Intervention/treatment
Experimental: CC-92480 in combination with bortezomib and dexamethasone
Subjects 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
Drug: CC-92480
CC-92480

Drug: Bortezomib
Bortezomib

Drug: Dexamethasone
Dexamethasone
Experimental: CC-92480 in combination with carfilzomib and dexamethasone
Subjects 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
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Carfilzomib
Carfilzomib
Experimental: CC-92480 in combination with daratumumab and dexamethasone
Subjects 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
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Daratumumab
Daratumumab
Outcome Measures
  • Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: From first subject first visit until 28 days after the last subject discontinues study treatment. ]
    Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment
  • 2. Dose-limiting Toxicities (DLT) [ Time Frame: UP to approximately 2 years from enrollment ]
    Number of participants with DLTs in the first cycle of the treatment
  • 3. Overall response rate (ORR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Defined as the proportion of subjects who achieve partial response (PR)or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria .
  • Secondary Outcome Measures: 1. Time-to-response (TTR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Time from first dose to the first documentation of response (PR or greater)
  • 2. Duration of response (DOR) [ Time Frame: Up to approximately 3 years from enrollment ]
    Time from the first documentation of response (PR or greater) to the first documentation of progressive disease (PD) or death
  • 3. Complete Response (CR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria
  • 4. Very good partial response (VGPR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 47 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Tsvetan Biyukov, MD Bristol-Myers Squibb

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03989414 History of Changes
  • Other Study ID Numbers: CC-92480-MM-002, U1111-1233-5619, 2018-004767-31
  • First Posted: June 18, 2019 Key Record Dates
  • Last Update Posted: April 24, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: CC-92480
    Newly Diagnosed Multiple Myeloma
    Multiple Myeloma
    Relapsed or Refractory Multiple Myeloma
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell