Status:
COMPLETED
Carfilzomib, Cyclophosphamide, Dexamethasone in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma
Lead Sponsor:
Singapore General Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
Brief 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 man...
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 36 mg/m2 on days 8,9,15 and 16 on a 2...
Eligibility Criteria
Inclusion
- Newly diagnosed Multiple Myeloma AND Transplant eligible AND
- High Risk as defined by:
- International Staging System 3 OR
- FISH abnormality of t(4,14), t(14;16), 17p deletion or 1q amp
- Patients must have evaluable myeloma, with at least one of the following (Assessed within 28 days of commencing the study)
- Serum M protein \>/= 0.5g/dL or
- Urine M protein \>200mg/24hr
- Serum free light chains \>100mg/mL (involved light chain) and abnormal k/l ratio
- For IgA patients who have no other means of measurement of disease, sIgA level \>0.75g/dL
Exclusion
- Relapsed Myeloma
- Non transplant eligible patient.
- IgM subtype Myeloma
- POEMS syndrome
- Amyloidosis
- Waldenstroms Macroglobulinemia
- Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days of randomization (Limited site radiation allowed).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02217163
Start Date
October 1 2014
End Date
October 1 2020
Last Update
October 20 2020
Active Locations (2)
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1
National University Hospital
Singapore, Singapore, 119074
2
Singapore General Hospital
Singapore, Singapore, 169608