Efficacy of Bortezomib, Lenalidomide and Dexamethasone combination therapy after Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma patients
Phase 2
- Conditions
- Health Condition 1: null- Patients with multiple myeloma post autologous hematopoeitic stem cell transplatation
- Registration Number
- CTRI/2017/06/008741
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 93
Inclusion Criteria
All multiple myeloma patients who have undergone Autologous Hematopoietic stem cell transplant will be enrolled at 100 days (± 2weeks) of post ASCT
Exclusion Criteria
1.ECOG Performance status 3 and 4
2.Uncontrolled diabetes and hypertension
3.peripheral neuropathy > grade 2
4.Any contraindication to anticoagulant prophylaxis
5.Persistent cytopenias >=1 cell line (Hb < 8 g/dl, Platelets < 1 x 105/cmm, ANC < 1000/cmm)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess response rate after post Autologous Hematopoietic Stem ceell transplantation consolidation therapyTimepoint: 1ST August, 2016 to 31st May, 2018
- Secondary Outcome Measures
Name Time Method 1.To assess for MRD negativity rate post consolidation therapy <br/ ><br>2.To assess for one year PFS <br/ ><br>3.To assess for toxicity of consolidation therapy <br/ ><br>Timepoint: 1ST August, 2016 to 31st May, 2018