A Single Arm Study of Carfilzomib in Transplant Eligible High Risk Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02217163|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Last Update Posted : April 19, 2018
Patients with high risk multiple myeloma have shorter remission periods and reduced overall survival. Prognostic significance of minimal residual disease negative remission is being highlighted in many of the newer studies.
The current phase 2 study investigates the combination of carfilzomib together with cyclophosphamide and dexamethasone in patients with high risk multiple myeloma in younger transplantation eligible patients.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Carfilzomib, Cyclophosphamide, Dexamethasone||Phase 2|
Carfilzomib is administered over 30 minutes as an infusion. For cycle 1 only, Carfilzomib is administered at 20mg/m2 IV on days 1 and 2, followed by escalation to 56mg/m2 on days 8,9,15 and 16 on a 28 day cycle. Patients who tolerate 56mg/m2 dose are kept at this dose for the subsequent cycles on Days 1,2,8,9,15,16 on a 28 day cycle. Dose and schedule modifications for intolerable side effects are detailed in the protocol. Additionally Cyclophosphamide is given a fixed dose of 500mg once per week orally, along with dexamethasone is given on the days of Carfilzomib administration, 30 minutes to 4 hours prior to Carfilzomib. Patients will undergo blood tests weekly and serum protein electrophoresis every 4 weeks during treatment.
Within completion of the 8 cycles of treatment patients would undergo stem cell collection using chemotherapy and growth factor mobilization. After completion of up to 8 cycles of treatment autologous bone marrow transplantation (BMT) will be conducted. Patients who achieve stringent CR before 8 cycles will undergo bone marrow biopsy for minimal residual disease (MRD) analysis by flow cytometry (MPFC). If MRD negativity by MPFC has been achieved, they may proceed directly to autologous BMT if possible, or if MRD positive, continue to complete 8 cycles of treatment and proceed to autologous BMT . Following bone marrow transplantation, there will be staging investigations including blood and bone marrow investigations and MRD analysis MPFC. Patients who achieve MRD negativity by MPFC will be managed expectantly by watch and wait. Patients who are MRD positive at this stage will undergo further consolidation and maintenance for 2 years or disease progression. Follow up would extend till a minimum of 2 years from completion of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE 2 SINGLE ARM STUDY OF CARFILZOMIB IN TRANSPLANT ELIGIBLE HIGH RISK MULTIPLE MYELOMA|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Myeloma treatment
The combination therapy with Carfilzomib, Cyclophosphamide and dexamethasone will be used to treat eligible patients for upto 8 cycles following which they will undergo autologous bone marrow transplantation. Following this there will disease assessment and further treatment decided afterwards.
Drug: Carfilzomib, Cyclophosphamide, Dexamethasone
Carfilzomib is administered over 30 minutes as an infusion. For cycle 1 only, Carfilzomib is administered at 20mg/m2 IV on days 1 and 2, followed by escalation to 56mg/m2 on days 8,9,15 and 16 on a 28 day cycle. Patients who tolerate 56mg/m2 dose are kept at this dose for the subsequent cycles on Days 1,2,8,9,15,16 on a 28 day cycle. Dose and schedule modifications for intolerable side effects are detailed in the protocol. Additionally Cyclophosphamide is given a fixed dose of 500mg once per week orally, along with dexamethasone is given on the days of Carfilzomib administration, 30 minutes to 4 hours prior to Carfilzomib.
- Progression Free Survival [ Time Frame: 2 years ]To study the progression free survival (PFS) in patients with newly diagnosed high risk multiple myeloma treated with Carfilzomib, Cyclophosphamide and Dexamethasone, followed by autologous bone marrow transplantation.
- Minimal residual disease negativity [ Time Frame: 2 years ]Minimal residual disease burden at different time points, as assessed my multi parameter flow cytometry
- Overall Survival [ Time Frame: 2 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): NCT02217163
|National University Hospital|
|Singapore General Hospital|
|Principal Investigator:||Yunxin Chen, MBBS||Singapore General Hospital|