The hypothesis is that the addition of daratumumab administered SC to standard multiple myeloma 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.
SparkCures ID | 967 |
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Trial Phase | Phase 2 |
Enrollment | 240 Patients |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Criteria:
Exclusion Criteria:
The following is a listing of trial locations that are open and accepting patients.
Jacksonville, FL
Orlando, FL
Southfield, MI
Billings, MT
Winston-Salem, NC
Omaha, NE
New York, NY
Sioux Falls, SD
Salt Lake City, UT
Jacksonville, FL
Orlando, FL
Southfield, MI
Billings, MT
Omaha, NE
New York, NY
Winston-Salem, NC
Sioux Falls, SD
Salt Lake City, UT
This trial has active trial locations in countries outside of the United States.
Our system currently only provides clinical trial matching services for myeloma patients in the United States.
You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.
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