Randomized clinical study to evaluate utility of response adapted treatment in patients with newly diagnosed multiple myeloma
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2021/11/037702
- Lead Sponsor
- Intramural grant of Tata Memorial Center Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 2: MRd negativity rates at 1 year from randomization <br/ ><br>Phase 2: PFS rated at 2 years from RandomizationTimepoint: Phase 2: MRd negativity rates at 1 year from randomization <br/ ><br>Phase 2: PFS rated at 2 years from Randomization
- Secondary Outcome Measures
Name Time Method Grade 3 or more SAE of MRD guided therapy.Timepoint: 1 year;Overall survival <br/ ><br>Timepoint: 2 years