Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma
Patients included in the study will receive induction treatment during 6 months, followed by receive high-dose therapy followed by peripheral blood stem cell transplantation.
Approximately 3 months after peripheral blood stem cell transplantation patients will receive consolidation treatment during 2 months.
Subsequently patients will start maintenance treatment during 24 months. Therefore, the total duration of the treatment will be approximately 36 months.
|Smoldering Multiple Myeloma||Drug: carfilzomib Drug: Lenalidomide Drug: Dexamethasone Drug: Melphalan||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of Carfilzomib, Lenalidomide and Dexamethasone (KRd) Plus High-dose Therapy With Melphalan and Autologous Stem Cell Transplantation, Followed by Consolidation With KRd, and Maintenance With Lenalidomide and Dexamethasone in Patients Under 65 Years With High Risk Smoldering Multiple Myeloma|
- Efficacy- Number of Immunophenotypic complete remission rate (Flow-CR) at day +100 after induction and HDT-ASCT [ Time Frame: 4 months ]Number of Immunophenotypic complete remission rate (Flow-CR) at day +100 after induction and HDT-ASCT
- Efficacy - Number of Response rates after the different parts of the treatment, induction, HDT-ASCT, consolidation and maintenance [ Time Frame: up to 24 weeks ]Number of Response rates after the different parts of the treatment, induction, HDT-ASCT, consolidation and maintenance
- Efficacy- Months to progression free survival [ Time Frame: 60 months ]Months to progression free survival
- Efficacy -Months to overall survival [ Time Frame: 60 months ]Months to overall survival
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||May 2020|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Experimental: Carlizomib lenalidomide and low dose dexamethasone
Induction treatment: patients included in the trial will receive an induction treatment for approximately 6 months (6 cycles of carfilzomib, lenalidomide and low dose dexamethasone (KRd)). After the third cycle of KRd, all patients will be mobilized with colony stimulating factor (G-CSF) alone to collect peripheral blood stem cell for the ASCT.
High dose therapy followed by autologous stem cell transplantation: patients will receive melphalan 200 mg/m2 via intravenous followed by autologous stem cell transplantation (HDT-ASCT).
Consolidation treatment: approximately 3 months after the autologous stem cell transplantation, patients will receive consolidation treatment for 2 months (2 cycles of carfilzomib, lenalidomide and low dose dexamethasone (KRd)).
Maintenance treatment: subsequently they will start a maintenance treatment that will be administered for approximately 24 months (24 cycles of lenalidomide and low dose dexamethasone
|Drug: carfilzomib Drug: Lenalidomide Drug: Dexamethasone Drug: Melphalan|
This clinical trial is a multicenter Phase II study designed to evaluate the efficacy and toxicity of an intensive therapeutic approach in 90 patients with asymptomatic high risk multiple myeloma (SMM).
- - Patients will receive an induction treatment consisting of 6 cycles of carfilzomib, lenalidomide and low-dose dexamethasone (KRd): patients will receive carfilzomib 20-36 mg/m2 IV on days 1, 2, 8, 9, 15 and 16; with oral lenalidomide 25 mg daily on days 1-21, subsequently there will be a rest period of a week (from day 22 to day 27). Moreover, oral dexamethasone 40mg daily will be administered weekly (days 1, 8, 15 and 22).
- - Following the induction treatment, patients will receive high-dose (200 mg/m2) melphalan-based treatment administered via the intravenous route followed by peripheral blood stem cell transplantation (HDT-ASCT).
- - The consolidation treatment will consist of 2 cycles of KRd, with the same doses and scheduled of the induction treatment.
- - Maintenance treatment: all patients, without progression to symptomatic multiple myeloma or toxicity requiring discontinuation of the trial, will receive maintenance treatment during 24 cycles.
This maintenance treatment comprises the administration of lenalidomide 10mg on days 1-21, followed by a rest period of 1 week, with the weekly administration of dexamethasone 20mg.
Treatment will be administrated until the end of the maintenance, although patients will continue in the trial.
If biological progression is observed following the discontinuation of the treatment, lenalidomide and dexamethasone will be reinstituted in order to control the disease again. Lenalidomide 10 mg will be administrated on days 1-21 combined with dexamethasone 20mg on days 1, 8, 15 and 22. All patients will be monitored for asymptomatic disease progression and to collect data regarding on overall survival (OS).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02415413
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