A Single Arm Study of Carfilzomib in Transplant Eligible High Risk Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carfilzomib, Cyclophosphamide, Dexamethasone
Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Newly diagnosed multiple myeloma AND Transplant eligible AND High Risk as defined by International staging system 3 OR Deletion 17p OR Amplification 1q OR transaction 4,14 OR translocation 14,16 OR translocation 14,20

Exclusion Criteria:

1. Relapsed Myeloma

2. Non Transplant eligible patient.

3. Ig M subtype Myeloma

4. POEMS syndrome

5. Amyloidosis

6. Waldenstroms Macroglobulinemia

7. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days of randomization-Limited site radiation allowed.
Locations
National University Hospital
Singapore, Singapore
Status: Not yet recruiting
Contact: Wee Joo Chng, MD - wee_joo_chng@nuhs.edu.sg
Singapore General Hospital
Singapore, Singapore
Status: Recruiting
Contact: Sathish Kumar, MD - +6562223322 - sathish.gopalakrishnan@sgh.com.sg
Start Date
October 2014
Completion Date
September 2018
Sponsors
Singapore General Hospital
Source
Singapore General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page