Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01049945|
Recruitment Status : Unknown
Verified April 2016 by Mayo Clinic.
Recruitment status was: Active, not recruiting
First Posted : January 15, 2010
Results First Posted : March 30, 2015
Last Update Posted : May 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma||Drug: bendamustine hydrochloride Drug: lenalidomide Drug: dexamethasone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Multicenter, Open-label, Dose-escalation Study of Bendamustine in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||November 2012|
Experimental: Arm I
Patients receive dexamethasone orally or IV on days 1, 8, 15, and 22; bendamustine hydrochloride IV over 30 minutes on days 1 and 2; and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: bendamustine hydrochloride
Given orally or IV
- Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I) [ Time Frame: One cycle of treatment ]
The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:
- Grade 2 neuropathy with pain
- Any grade 3 Non-Hematologic toxicity
- Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days.
- Grade 4 neutropenia
- Febrile neutropenia
- Grade 4 thrombocytopenia
- Grade 3 thrombocytopenia associated with bleeding
- Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days.
We are reporting the results of this endpoint as the number of DLTs per dose level.
- Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR). [ Time Frame: Up to 6 cycles of treatment ]
Complete response (CR)
- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow
Near complete response (nCR) A CR, with the persistence of original monoclonal protein
Very good partial response (VGPR)
- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h
Partial response (PR)
- ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.
- a ≥50% decrease in the difference between involved and uninvolved FLC levels
- or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline.
- Duration of Response (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]
- Time to Progression (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]
- Progression Free Survival (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]
- Overall Survival (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]
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): NCT01049945
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 55904|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637-1470|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington Universtiy School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Study Chair:||Shaji K. Kumar, M.D.||Mayo Clinic|
|Principal Investigator:||Vivek Roy, M.D.||Mayo Clinic|