CTRI/2021/11/037702
Recruiting
Phase 3
Minimal residual disease guided therapy in newly diagnosed multiple myeloma. - Safetyof MRD guided VRd consolidation
Intramural grant of Tata Memorial Center Mumbai0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Sponsor
- Intramural grant of Tata Memorial Center Mumbai
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<3\.0Xupper limit of Normal ULN;bilirubin \<1\.5XLNS
- •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
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
Outcomes
Primary Outcomes
Not specified
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