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 : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: daratumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 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|
|Estimated Primary Completion Date :||July 17, 2020|
|Estimated Study Completion Date :||July 16, 2021|
|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, and every 8 weeks after Cycle 20, in case treatment will be extended as per investigator discretion, if there is a positive benefit/risk ratio, absence of Grade greater than or equal to (>=) 3 treatment related toxicity, and at least stable disease has been achieved. 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, and every 8 weeks after Cycle 20, in case treatment will be extended as per investigator discretion, if there is a positive benefit/risk ratio, absence of Grade >=3 treatment related toxicity, and at least stable disease has been achieved. 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 5 years ]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 5.5 years ]
- 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 is defined as time from date of randomization to date of initial documented disease progression (PD) according to SLiM-CRAB (S=sixty, Li=light chains, M=MRI, C=calcium [elevated], R=renal failure, A=anemia, B=bone lesions) criteria, myeloma defining events, or date of death, whichever occurs first. As per SLiM-CRAB criteria, clonal bone marrow plasma cell percentage >=60%, Involved : uninvolved serum free Li ratio >= 100, >1 focal lesion on MRI studies, calcium elevation: >0.25 millimole per liter (mmol/L) ( >1 milligram per deciliter [mg/dL]) higher than upper limit of normal or >2.75 mmol/L (>11 mg/dL); creatinine clearance <40 milliliter per minute (mL/min) or serum creatinine >177 micromole per liter (µmol/L) (>2 mg/dL); hemoglobin <10 gram per deciliter (g/dL) (<6.5 mmol/L) or >2 g/dL (>1.25 mmol/L) lower than lower limit of normal; 1 or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT).
- 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|