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  • NCT02773030

Active, Not Recruiting

A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma - CC-220-MM-001

Updated: 21 June, 2024   |   ClinicalTrials.gov

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Cohort A: CC-220 Monotherapy - Part 1
Drug: CC-220
Experimental: Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1
Drug: CC-220, Dexamethasone
Experimental: Cohort C: CC-220 Monotherapy in RRMM - Part 2
Drug: CC-220
Experimental: Cohort D: CC-220 in combination with Dexamethasone - Part 2
Drug: CC-220, Dexamethasone
Experimental: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1
Drug: CC-220, Dexamethasone, Daratumumab
Experimental: Cohort F: CC-220 with DEX and bortezomib - Part 1
Drug: CC-220, Dexamethasone, Bortezomib
Experimental: Cohort G1: CC-220 in combination with CFZ and DEX - Part 1
Drug: CC-220, Dexamethasone, Carfilzomib
Experimental: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1
Drug: CC-220, Dexamethasone, Carfilzomib
Experimental: Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2
Drug: CC-220, Dexamethasone
Experimental: Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2
Drug: CC-220, Dexamethasone, Bortezomib
Experimental: Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2
Drug: CC-220, Dexamethasone, Bortezomib
Experimental: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2
Drug: CC-220, Dexamethasone, Daratumumab

Key Eligibility Criteria

Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 - Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy - Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM) - Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation Exclusion Criteria: - Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study - Nonsecretory multiple myeloma - Prior history of malignancies, other than MM and select non-invasive malignancies, unless the participant has been free of the disease for ≥ 5 years Other protocol-defined inclusion/exclusion criteria apply

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001