Phase-IV clinical trial of Carfilzomib Injection to to see the response in relapsed or refractory multiple myeloma patients
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2019/03/018248
- Lead Sponsor
- atco Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients aged >=18 years
2. Relapsed and/or refractory multiple myeloma at study entry.(It is defined either the lack of response or disease progression on or within 60 day of the last therapy)
3. Received one, but not more than three prior treatment regimens or lines of therapy for multiple myeloma
1. Glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last three weeks
2.POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
3. Plasma cell leukemia
4. Chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy, within the three weeks prior to first dose
5. Radiation therapy or immunotherapy in the previous four weeks, localized radiation therapy within 1 week prior to first dose
6. Participation in an investigational therapeutic study within three weeks or within five drug half-lives (t1/2) prior to first dose, whichever time is greater
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease response evaluation will be assessed based on the <br/ ><br>change in the Serum M Protein levels and Serum free light chains from the baseline. <br/ ><br>Timepoint: 1 28 56 and 84
- Secondary Outcome Measures
Name Time Method Adverse events, vital signs, laboratory tests will be monitored during the study <br/ ><br>Timepoint: 1, 28, 56 and 84 day