Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03221634
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • Daratumumab — BIOLOGICAL
    IV infusion

Study Details

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with daratumumab in participants with relapsed refractory multiple myeloma (rrMM). The primary outcome measure for this study is the assessment of Objective Response Rate (ORR) in participants with rrMM.

Key Dates

Start date
Aug 1, 2017
Status verified
Mar 2019
Primary completion
Mar 20, 2019
Completion
Jun 10, 2021

Study Design

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

Arms

  • Experimental: Pembrolizumab
    Participants receive pembrolizumab 200 mg by intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 administrations (up to approximately 2 years) and receive daratumumab 16 mg/kg by IV infusion on Days 1, 8, 15, and 22 of Cycles 1-2; on Days 1 and 15 of Cycles 3-6, and on Day 1 of Cycle 7 and beyond, for up to 2 years. Each cycle is 28 days long.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic Jacksonville ( Site 0003)JacksonvilleFlorida32224-
Emory University School of Medicine ( Site 0002)AtlantaGeorgia30322-
Karmanos Cancer Institute ( Site 0001)Bloomfield HillsMichigan48302-

Find similar trials in Jacksonville, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Jacksonville· Jacksonville, FLEmory University School of Medicine· Atlanta, GAKarmanos Cancer Institute· Bloomfield Hills, MI

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