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Protocol # 19-054

Status

Recruiting

Description

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 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

Condition

  • Multiple Myeloma

Interventions

  • CC-220
  • Dexamethasone
  • Daratumumab
  • Bortezomib
  • Carfilzomib

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment
  • Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment
  • Overall response rate (ORR) of CC-220 in combination with Dexamethasone (DEX) in Cohort D

Secondary Outcome:

  • Adverse Events (AEs)
  • Overall response rate (ORR)
  • Time to Response (TTR)
  • Duration of Response (DOR)
  • Progression-free Survival (PFS)
  • Overall Survival (OS) in Part 2 relapsed and refractory multiple myeloma (RRMM) cohorts
  • Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval (AUC[TAU])
  • Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
  • Pharmacokinetics - Time to maximum plasma concentration of drug (Tmax)
  • Very good partial response or better rate (VGPR)

Enrollment

449

Study Start Date

October 14, 2016

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Celgene

Source

Celgene

Official title

A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma

Clinicaltrials.gov Identifier

NCT02773030

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.