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Trial ID CC-220-MM-001  |   NCT02773030

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

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

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 monotherapy and CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma (RRMM), CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX and DARA for Newly Diagnosed Multiple Myeloma (NDMM).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
    1. 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
      1. Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM)
        1. 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

          Exclusion Criteria Icon
          :
          • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
            1. Nonsecretory multiple myeloma
              1. 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
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Cohort A: CC-220 Monotherapy - Part 1

                ASSIGNED INTERVENTION
                • Drug: CC-220

                Study Arms

                Experimental: Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1

                ASSIGNED INTERVENTION
                • Drug: CC-220, Dexamethasone

                Study Arms

                Experimental: Cohort C: CC-220 Monotherapy in RRMM - Part 2

                ASSIGNED INTERVENTION
                • Drug: CC-220

                Study Arms

                Experimental: Cohort D: CC-220 in combination with Dexamethasone - Part 2

                ASSIGNED INTERVENTION
                • Drug: Dexamethasone, CC-220

                Study Arms

                Experimental: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1

                ASSIGNED INTERVENTION
                • Drug: CC-220, Daratumumab, Dexamethasone

                Study Arms

                Experimental: Cohort F: CC-220 with DEX and bortezomib - Part 1

                ASSIGNED INTERVENTION
                • Drug: CC-220, Bortezomib, Dexamethasone

                Study Arms

                Experimental: Cohort G1: CC-220 in combination with CFZ and DEX - Part 1

                ASSIGNED INTERVENTION
                • Drug: Dexamethasone, Carfilzomib, CC-220

                Study Arms

                Experimental: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1

                ASSIGNED INTERVENTION
                • Drug: Dexamethasone, Carfilzomib, CC-220

                Study Arms

                Experimental: Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2

                ASSIGNED INTERVENTION
                • Drug: CC-220, Dexamethasone

                Study Arms

                Experimental: Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2

                ASSIGNED INTERVENTION
                • Drug: CC-220, Dexamethasone, Bortezomib

                Study Arms

                Experimental: Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2

                ASSIGNED INTERVENTION
                • Drug: CC-220, Dexamethasone, Bortezomib

                Study Arms

                Experimental: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2

                ASSIGNED INTERVENTION
                • Drug: CC-220, Dexamethasone, Daratumumab

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