A study to see the response of drugs Melphalan,Prednisolone and lenalidomide in the treatment of elderly patients,diagnosed as Multiple Myeloma(A type of cancer)

Not Applicable

• Conditions: Health Condition 1: null- Elderly Multiple Myeloma Patients (Age above 60)

• Registration Number: CTRI/2013/04/003565
• Lead Sponsor: Dr Geetha

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Written informed consent

Newly diagnosed MM > 65 yrs of age based on the myeloma diagnostic criteria (Appendix A)

Patients more than 60 years of age but not eligible for Bone marrow transplant

Not received previous systemic treatment for MM (except steroids for less than 14 days)

Performance status of <= 2 on ECOG performance scale (Appendix C)

Note: Patients who are bedridden due to local cause(eg. Back ache) will be considered for the study.

Patient has measurable disease, defined as any quantifiable serum M protein value and / or when applicable, urine M protein >= 200 mg/ 24 hrs or bone marrow plasma cells > 10%.

Patient must have adequate organ function as indicated by the lab tests (Hemoglobin > 8 g/dL, Platelet count > 75000/mm³, ANC > 1,000/mm³, Creatinine < 2.5 mg/dL, Direct bilirubin <= 1.5 mg/dL, ALT and AST <= 2.5 times upper limit of normal(ULN))

Exclusion Criteria

1.Patient has uncontrolled inter current infections or circumstances that could limit compliance with the study â?? renal failure, uncontrolled hypertension, symptomatic CCF, angina pectoris, MI in the past 6 months, uncontrolled cardiac arrhythmias

2.Patient has known hyper sensitivity to any components of the study regimen

3.Patient has a history of illicit drug use/substance abuse

4.Patient is known to be HIV positive

5.Patient has clinically active hepatitis B/C defined as disease that requires specific therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
remission rate,disease free survival,quality of life assessmentTimepoint: 3 monthly

Secondary Outcome Measures

Name	Time	Method
1.Time to progression and overall survival <br/ ><br>2.Toxicity profile of MPL regime <br/ ><br>3.QoL <br/ ><br>Timepoint: 3 monthly