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Protocol # 20-074

Status

Recruiting

Description

A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.

Condition

  • Myeloma, Multiple

Interventions

  • Lenalidomide
  • Ixazomib
  • Daratumumab Injection
  • Dexamethasone

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Impact of Study Treatment on Progression Free Survival (PFS)

Secondary Outcome:

  • Minimal Residual Disease (MRD)
  • Toxicity Profile of Treatment Arm Based on Patient Response
  • Overall Response Rate (ORR)
  • Overall Survival (OS)
  • Quality of Life with the EQ 5D 5L Questionnaire
  • Quality of Life with the EORTC QLQ-MY20 Questionnaire
  • Quality of Life with the EORTC QLQ-C30 Questionnaire
  • Rate of Adherence to Lenalidomide and Ixazomib
  • Alliance Geriatric Assessment with IMWG Fragility Score

Enrollment

188

Study Start Date

October 21, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     75 Years
  • Healthy volunteers:     No

Sponsors

Alliance Foundation Trials, LLC.

Source

Alliance Foundation Trials, LLC.

Official title

A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma

Clinicaltrials.gov Identifier

NCT04009109

     

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.