Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Andrew Yee, MD
Study ID
NCT04119336
Phase
PHASE2
Status
Terminated

Conditions

  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Given intravenously once per cycle
  • Ixazomib — DRUG
    Given orally on days 1, 8, 15.
  • Dexamethasone — DRUG
    Given orally on days 1, 8, 15, 22
  • Cyclophosphamide — DRUG
    Given intravenously on days 1, 8, 15.

Study Details

This research is being done to assess the effectiveness and safety of the combination of nivolumab with ixazomib, cyclophosphamide, and dexamethasone in relapsed and refractory multiple myeloma.

Key Dates

Start date
Feb 14, 2020
Status verified
Aug 2023
Primary completion
Nov 12, 2020
Completion
Mar 30, 2022

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Ixazomib
    \- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 8 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Mass General/North Shore Cancer CenterDanversMassachusetts01923-

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