Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Carfilzomib Injection 60 mg: CARFILNAT is administered intravenously over 2 to 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by
Sponsors
Natco Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease response evaluation will be assessed based on the change in the Serum M Protein levels and Serum free light chains from the baseline. Timepoint: 1 28 56 and 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, vital signs, laboratory tests will be monitored during the study Timepoint: 1, 28, 56 and 84 day | — |
Countries
India
Contacts
Public ContactDr Sadashivudu Gundeti
Nehru hospital Postgraduate Institute of Medical Education and Research
Outcome results
None listed