Last updated on September 2018

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens


Brief description of study

The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

Detailed Study Description

The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.

Clinical Study Identifier: NCT03412565

Contact Investigators or Research Sites near you

Start Over

Study Contact

Queens Medical Associates, PC
Fresh Meadows, NY United States
0.74miles
  Connect »

Study Contact

Northwell Health
Lake Success, NY United States
5.47miles
  Connect »

Study Contact

NYU Winthrop
Mineola, NY United States
8.16miles
  Connect »

Study Contact

Mt. Sinai School of Medicine
New York, NY United States
8.68miles
  Connect »