A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Part of paid clinical trials in Duarte, California.

Sponsor
Celgene
Study ID
NCT03000452
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts; Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly \[QW\], every 2 weeks \[Q2W\] or every 4 weeks \[Q4W\] of each 28-day cycle) received on their last prior therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.

Key Dates

Start date
Mar 14, 2017
Status verified
Sep 2018
Primary completion
Sep 18, 2017
Completion
Dec 4, 2017

Study Design

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

Arms

  • Experimental: Administration of Daratumumab (DARA) plus Durvalumab (DURVA)
    Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly \[QW\], every 2 weeks \[Q2W\], or every 4 weeks \[Q4W\] of each 28-day treatment cycle) received during their last prior therapy containing DARA at the time of DARA progression

Primary Outcome Measure

Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria [ Time Frame: From randomization until the data cut-off date of 17 April 2018. The median duration of treatment for durvalumab and daratumumab was 7.9 weeks and 8.0 weeks respectively. ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-300-
Cancer Center of Central ConnecticutSouthingtonConnecticut06489-
Parkview Research CenterFort WayneIndiana46845-
Indiana University Cancer CenterIndianapolisIndiana46202-528-
University of Kansas HospitalWestwoodKansas66205-
University of Maryland School of MedBaltimoreMaryland21201-1595-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Morristown Memorial HospMorristownNew Jersey07962-
OHSUPortlandOregon97201-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope Cancer Center· Duarte, CACancer Center of Central Connecticut· Southington, CTParkview Research Center· Fort Wayne, INIndiana University Cancer Center· Indianapolis, INUniversity of Kansas Hospital· Westwood, KSUniversity of Maryland School of Med· Baltimore, MD

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