A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma (NCT02316106) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
United States123 participantsStarted 2015-05-20
Plain-language summary
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
* Have a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion Criteria:
* Active multiple myeloma,requiring treatment as defined by the study protocol
* Primary systemic AL (immunoglobulin light chain) amyloidosis
* Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with corticosteroids with a dose greater than (\>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
* History of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
* Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
* Any concurrent medical or …
What they're measuring
1
Percentage of Participants Who Achieved a Complete Response (CR) by International Myeloma Working Group (IMWG) Criteria