Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Arm B: Standard dose chemotherapy with VRd regimen till MRD negativity is achieved followed by maintenance: Inj. Bortezomib 1.3 mg/m2 weekly Tab. Lenalidomide 25 mg Day 1-21 followed by
Sponsors
Intramural grant of Tata Memorial Center Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1.patient with histologically proven PCNSL 2. Received methotrexate based induction therapy 3. Radio logical consolidation therapy after achieving CR 5.Age >18 years 6.PS >2 after the completion of consolidation therpy 7.Adequate bone marrow function with absolute leukocytes >2000mm3,neutrophil count ANC >1000/mm3.haemoglobin >8g/dl and platelets >100000/mm3 8.Adecute liver function with serum SGOT/AST or SGPT/ALT 9.Creatinineclearance >30ml/min.Patients with calculated ceratine cleearance between 30 and 60 ml/min lenalidomide dose will be adjusted as follows(10 mg oncedalily) 10.Able to take aspirin(75mg) daily as prophylactic anticoagulant 11.Able to understand the teratogenicity 12.Men and women of child bearing age should agree to use reliable contraception 13. Neuropathy of >grade 2 severity 14.Able to understand and sign inform consent
Exclusion criteria
Exclusion criteria: Diagnosis of sleep apnea or any other chronic respiratory disease • Any acute or chronic condition that would limit the ability of the patient to participate in the study • Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: MRd negativity rates at 1 year from randomization Phase 2: PFS rated at 2 years from RandomizationTimepoint: Phase 2: MRd negativity rates at 1 year from randomization Phase 2: PFS rated at 2 years from Randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade 3 or more SAE of MRD guided therapy.Timepoint: 1 year;Overall survival Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Bhausaheb Bagal
Tata Memorial Center
Outcome results
None listed