A clinical trial to study the effects of two drugs, Lenalidomide and Thalidomide given with low dose of Dexamethasone in patients with Multiple Myeloma
Phase 3
- Conditions
- Health Condition 1: null- Multiple MyelomaHealth Condition 2: C900- Multiple myeloma
- Registration Number
- CTRI/2015/06/005944
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a) Age 18 to 70 years
b) Adequate hemogram, liver, heart and kidney function
c) Performance status 0 to 2 (ECOG)
d) Two negative pregnancy tests (one before and the second 4 weeks after starting Thalidomide or Lenalidomide)
e) Willingness to participate in the study
Exclusion Criteria
Hypersensitivity reaction to Thalidomide or Lenalidomide in the past
b) Pre-existing peripheral neuropathy more than grade 2
c) Uncontrolled diabetes mellitus
d) Renal failure
e) Significant ischemic cardiac disease eg LBBB
f) Uncontrolled psychiatric (depressive) disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare progression-free survival between patients on Thalidomide and Lenalidomide maintenance <br/ ><br> <br/ ><br>Timepoint: At the end of 3 years
- Secondary Outcome Measures
Name Time Method 1.To evaluate the acute and cumulative toxicity of the Thalidomide and Lenalidomide<br><br>2. To compare the effect of maintenance therapy on the patient?s Quality of Life<br><br>3.To determine the rate of conversion from partial response (PR) or very good partial response (VGPR) to VGPR or complete response (CR) respectively<br><br>4. To identify those patients who are need and are likely to benefit from maintenance therapy<br><br>Timepoint: At the end of 3 years