Treament of multiple myeloma
Phase 2
- Conditions
- Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
- Registration Number
- CTRI/2019/09/021385
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a)Newly diagnosed patients with multiple myeloma
b)Age between 18-60years
Exclusion Criteria
a)Creatinine clearance <30 or patients on dialysis
b)Venous thromboembolism at diagnosis
c)Past history of venous thromboembolism
d)Hepatic dysfunction â?? Bil > 2, AST/ALT >4 times ULN
e)Grade 3-4 peripheral neuropathy
f)Pregnancy
g)Not able to understand the investigative nature of the study or give consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a.Complete response after 4 cycles of therapy <br/ ><br> <br/ ><br>Timepoint: 4 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method a.Overall response rates after 4 cycles <br/ ><br>b.MRD (minimal residual disease) negativity after 4 cycles <br/ ><br>c.Three-year event free survival <br/ ><br>d.Three-year overall survival <br/ ><br>e.The incidence of grade 3 and 4 adverse events <br/ ><br>Timepoint: 4 months