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Protocol # 19-893

Status

Active, not recruiting

Description

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

Condition

  • Multiple Myeloma

Interventions

  • CC-93269

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Adverse Events (AEs)
  • Dose Limiting Toxicity (DLT)
  • Non-Tolerated Dose (NTD)
  • Maximum Tolerated Dose (MTD)

Secondary Outcome:

  • Overall Response Rate (ORR)
  • Time to Response
  • Duration of Response
  • Progression Free Survival
  • Overall Survival
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - Cmin
  • Pharmacokinetics - AUC
  • Pharmacokinetics - tmax
  • Pharmacokinetics - t1/2
  • Pharmacokinetics - CL
  • Pharmacokinetics - Vss
  • Pharmacokinetics - accumulation index of alnuctamab
  • Presence and frequency of anti-drug antibodies (ADA)
  • Evaluate measures of tumor sensitivity/ resistance to CC-93269

Enrollment

220

Study Start Date

April 3, 2018

Eligibility

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

Sponsors

Celgene

Source

Celgene

Official title

A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma

Clinicaltrials.gov Identifier

NCT03486067

     

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.