Health Condition 1: null- Elderly Multiple Myeloma Patients (Age above 60)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate,disease free survival,quality of life assessmentTimepoint: 3 monthly | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to progression and overall survival 2.Toxicity profile of MPL regime 3.QoL Timepoint: 3 monthly | — |
Countries
India
Contacts
Dept. of Medical Oncology, Regional Cancer Centre, Trivandrum