A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03187262
Phase
PHASE2
Status
Completed

Conditions

  • Waldenström Macroglobulinemia

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories

Study Details

This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.

Key Dates

Start date
Nov 27, 2017
Status verified
Nov 2022
Primary completion
Jan 31, 2021
Completion
Dec 31, 2021

Study Design

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

Arms

  • Experimental: Daratumumab
    * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle

Primary Outcome Measure

Overall Response Rate [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
Mayo ClinicRochesterMinnesota55905-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
University of WashingtonSeattleWashington98109-

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