|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02217163 |
|
Date of registration:
|
12/08/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Carfilzomib, Cyclophosphamide, Dexamethasone in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma
|
|
Scientific title:
|
Study of Carfilzomib in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma |
|
Date of first enrolment:
|
October 2014 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02217163 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Contacts
|
|
Name:
|
Chandramouli Nagarajan, MBBS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Singapore General Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Newly diagnosed Multiple Myeloma AND Transplant eligible AND
2. High Risk as defined by:
- International Staging System 3 OR
- FISH abnormality of t(4,14), t(14;16), 17p deletion or 1q amp
3. 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 Criteria:
1. Relapsed Myeloma
2. Non transplant eligible patient.
3. IgM 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).
Age minimum:
21 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Multiple Myeloma
|
|
Intervention(s)
|
|
Drug: Carfilzomib, , Cyclophosphamide, Dexamethasone
|
|
Primary Outcome(s)
|
|
Progression Free Survival
[Time Frame: 2 years]
|
|
Secondary Outcome(s)
|
|
Overall Survival (OS)
[Time Frame: 2 years]
|
|
Minimal residual disease negativity
[Time Frame: 2 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|