A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02316106|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2014
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: daratumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma|
|Actual Study Start Date :||May 20, 2015|
|Actual Primary Completion Date :||August 8, 2017|
|Estimated Study Completion Date :||July 20, 2020|
|Experimental: Arm A (Long Intense)||
16 mg/kg administered by intravenous (IV) infusion once every week in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. Treatment cycles are 8 weeks in length.
|Experimental: Arm B (Intermediate)||
16 mg/kg administered by IV infusion once every week in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20. Treatment cycles are 8 weeks in length.
|Experimental: Arm C (Short Intense)||
16 mg/kg administered by IV infusion once every week in Cycle 1 only. Treatment cycles are 8 weeks in length.
- The percentage of participants who achieve a complete response (CR) [ Time Frame: Up to approximately 24 months ]CR, defined having negative immunofixation on the serum and urine, and <5% plasma cells (PCs) in bone marrow.
- The percentage of participants that have an event (disease progression or death) per patient-year [ Time Frame: Up to approximately 30 months ]
- The percentage of participants who are minimal residual disease (MRD) negative [ Time Frame: Up to 5.5 years ]
- Time to next treatment (TNT) [ Time Frame: Up to 5.5 years ]TNT, defined as the time from the date of randomization to the date of the first subsequent multiple myeloma treatment.
- The percentage of participants who achieve a Complete Response (CR) or a Partial Response (PR) [ Time Frame: Up to 5.5 years ]See definition of CR above. PR, defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours.
- The median time of progression free survival (PFS) [ Time Frame: Up to 5.5 years ]PFS, defined as the time from the date of randomization to the date of initial documented disease progression (PD) or date of death, whichever occurs first.
- The percentage of participants with symptomatic multiple myeloma [ Time Frame: Up to 5.5 years ]
- Response to first subsequent multiple myeloma treatment [ Time Frame: Up to 5.5 years ]
- Overall survival rate [ Time Frame: Up to 5.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316106
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|