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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: - 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

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: Dexamethasone, CC-220

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, Dexamethasone, Daratumumab

Study Arms

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

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

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: CC-220, Dexamethasone, Carfilzomib

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