Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Bortezomib based regime: A. Bortezomib + Lenalidomide + Dexamethasone (VRd)
q28 days cycle:
1. Injection Bortezomib 1.3mg/m2 subcutaneously OD on days 1,8,15,22
2. Capsule Lenalidomide 25 mg OD Orally daily on days 1-21
3. Tablet Dexamethasone 40 mg OD after food on days 1,8,
q28 days cycle:
1. Patients receive Carfilzomib Cycle 1: 40 mg/m 2 IV infusion over 30 minutes on day 1 and 54 mg/m 2 IV
infusion over 30 minutes on days 8,15
Cycle 2 onwards: 54 mg/m 2 IV infusion ov
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: • 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) o Serum involved free light chain (SFLC) >= 100 mg/L and abnormal serum immunoglobulin kappa to lambda free light chain ratio ( 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.
Exclusion criteria
Exclusion criteria: 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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To compare response rates after 4 cycles of induction therapy in the two treatment arms as per standard IMWG response criteria. â?¢ To compare the adverse effects in the two treatment arms as per the CTCAE 5.0 guidelines. Timepoint: after 4 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Jasmine Porwal
AIIMS Rishikesh
Outcome results
None listed