A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Celgene
Study ID
NCT02616640
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
  • Pomalidomide — DRUG
  • Dexamethasone — DRUG

Study Details

This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen. On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

Key Dates

Start date
Jan 11, 2016
Status verified
Aug 2024
Primary completion
Nov 23, 2018
Completion
Jul 30, 2024

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab monotherapy
    Intravenous (IV) durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle
  • Experimental: Durvalumab + pomalidomide (POM)
    IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle and Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle
  • Experimental: Durvalumab + pomalidomide (POM) + dexamethasone (dex)
    IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle with Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle and Oral dex 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle

Primary Outcome Measure

Dose-limiting Toxicities (DLTs) [ Time Frame: Approximately 1 month ]

Locations (8)

FacilityCityStateZIPSite coordinators
Local Institution - 102BaltimoreMaryland21231-
Local Institution - 108BostonMassachusetts02115-
Local Institution - 114BostonMassachusetts02114-
Local Institution - 115BostonMassachusetts02215-
Local Institution - 105New YorkNew York10065-
Local Institution - 106CharlotteNorth Carolina28204-
Local Institution - 110ClevelandOhio44195-
Local Institution - 107MilwaukeeWisconsin53226-

Find similar trials in Baltimore, MD

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Local Institution - 102· Baltimore, MDLocal Institution - 108· Boston, MALocal Institution - 114· Boston, MALocal Institution - 115· Boston, MALocal Institution - 105· New York, NYLocal Institution - 106· Charlotte, NC

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