Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant (CARAMEL 2)
|Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma||Drug: carfilzomib Drug: dexamethasone Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Trial of Carfilzomib Consolidation After Autologous Stem Cell Transplantation for Multiple Myeloma(CARAMEL 2)|
- Rate of complete response [ Time Frame: Up to 5 years ]The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
- Overall survival [ Time Frame: Time from registration to death due to any cause, assessed up to 5 years ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Progression-free survival [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 5 years ]The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
- Time to progression post SCT [ Time Frame: Time from SCT to the earliest day with documentation of disease progression, assessed at 1 year post-SCT ]The distribution of time to progression will be estimated using the method of Kaplan-Meier.
- Time to progression post SCT [ Time Frame: Time from SCT to the earliest day with documentation of disease progression, assessed at 2 years post-SCT ]The distribution of time to progression will be estimated using the method of Kaplan-Meier.
- Maximum grade for each type of adverse event [ Time Frame: Up to 30 days after last day of treatment ]Frequency tables will be reviewed to determine adverse event patterns.
|Study Start Date:||August 2013|
|Study Completion Date:||October 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (carfilzomib, dexamethasone)
Patients receive carfilzomib IV over 30 minutes and dexamethasone PO on days 1, 2, 15, and 16. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: dexamethasone
Other Names:Other: laboratory biomarker analysis
I. To assess the complete response (CR) rate with carfilzomib and dexamethasone consolidation following an upfront single stem cell transplant (SCT).
I. To assess the toxicity of carfilzomib and dexamethasone when used as consolidation therapy in patients post SCT.
II. To determine the progression free rate at 1 and 2 years post SCT. III. To evaluate progression-free survival and overall survival.
I. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status.
II. To assess the HevyLite assay prior to and during treatment.
Patients receive carfilzomib intravenously (IV) over 30 minutes and dexamethasone orally (PO) on days 1, 2, 15, and 16. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 3 years and then every 6 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812720
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Shaji Kumar||Mayo Clinic|