A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
Celgene
Study ID
NCT02807454
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3). 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
Jul 7, 2016
Status verified
Feb 2023
Primary completion
Jan 3, 2022
Completion
Jan 3, 2022

Study Design

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

Arms

  • Experimental: Daratumumab Plus Durvalumab Treatment
    * Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle * IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward
  • Experimental: Pomalidomide+ Daratumumab+ Durvalumab+ Dexamethasone Treatment
    * Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle * IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward * oral POM at 4mg/day on days 1 to 21 * oral/IV dex at 40mg/day (\>75 years old) or 20mg/day (\>75 years old) on days 1, 8, 15 and 22

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From first dose to up to approximately 66 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
UCLA Division of Hematology OncologyLos AngelesCalifornia90095-1752-
Colorado Blood Cancer InstituteDenverColorado80218-
Local Institution - 007DenverColorado80218-
Emory University HospitalAtlantaGeorgia30322-
University of Chicago Medical CenterChicagoIllinois60637-
Center For Cancer and Blood DisordersBethesdaMaryland20817-
Dana-Farber Partners Cancer Care, Inc.BostonMassachusetts02115-
Washington UniversitySt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
University of Pennsylvania - Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Tennessee Oncology Nashville Drug Development UnitNashvilleTennessee37203-
Swedish Medical CenterSeattleWashington98104-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CAUCLA Division of Hematology Oncology· Los Angeles, CAColorado Blood Cancer Institute· Denver, COLocal Institution - 007· Denver, COEmory University Hospital· Atlanta, GAUniversity of Chicago Medical Center· Chicago, IL

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