Effectiveness of Carfilzomib containing combination vs Bortezomib containing combination in newly diagnosed multiple myeloma patients.
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2022/05/042759
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
•Patients of newly diagnosed symptomatic multiple myeloma (as per IMWG38 diagnostic criteria), of age >= 18 years & any gender, who are willing to participate in the study.
•Patients with measurable disease as defined by >= 1 of the following criteria, obtained within 1 month of randomization:
o > 1 g/dL monoclonal protein on serum protein electrophoresis (SPEP)
o > 200 mg/24 hours of monoclonal protein on a 24 hour urine protein electrophoresis (UPEP)
oSerum involved free light chain (SFLC) >= 100 mg/L and abnormal serum immunoglobulin kappa to lambda free light chain ratio ( < 0.26 or > 1.65)
•Life expectancy >= 6 months.
•Written informed consent.
•Patients with a history of prior malignancy who have been treated with curative intent and do not require active therapy.
•If there is no residual toxicity related to prior radiation given to symptomatic lesions, patient can be included in the study.
Pregnant women
Nursing women
Patients who have received more than one cycle (4 weeks or less) and 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic multiple myeloma.
Patients with uncontrolled hypertension or diabetes, New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF), unstable angina, myocardial infarction within previous 6 months, Grade 3 conduction abnormalities unless patient has a pacemaker, history of torsade de pointes, QTc prolongation ( >450 msec), left ventricular ejection fraction <40%, uncontrolled arrhythmia, sick sinus syndrome, or any medical condition that would compromise with compliance with protocol and therapy.
Patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM).
Patients with peripheral neuropathy ( grade 3-4 or lower grade with pain) by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.37
Patients having severe, uncontrolled illness.
Plasma cell leukemia ( absolute plasma cell count > 2 x 109/L or 20 percent of peripheral white blood cells).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To compare response rates after 4 cycles of induction therapy in the two treatment arms as per standard IMWG response criteria. <br/ ><br>â?¢To compare the adverse effects in the two treatment arms as per the CTCAE 5.0 guidelines. <br/ ><br>Timepoint: after 4 months of treatment
- Secondary Outcome Measures
Name Time Method â?¢To compare imaging plus MRD-response after induction in the two treatment arms as per IMWG MRD criteria.Timepoint: After 4 months of treatment