Skip to content

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)

PROSPECTIVE STUDY OF MELPHALAN, PREDNISOLONE AND LENALIDOMIDE IN THE TREATMENT OF ELDERLY PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/04/003565
Enrollment
50
Registered
2013-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Melphelan, Prednisolone, Lenalidomide (MPL): Observing the response to tretament with MPL therapy in elderly patients which is the standard of care in our institution. Doses are Tab Mel

Sponsors

Dr Geetha N
Lead Sponsor

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

MeasureTime frame
remission rate,disease free survival,quality of life assessmentTimepoint: 3 monthly

Secondary

MeasureTime frame
1.Time to progression and overall survival 2.Toxicity profile of MPL regime 3.QoL Timepoint: 3 monthly

Countries

India

Contacts

Public ContactDrPPAbdul Shahid

Dept. of Medical Oncology, Regional Cancer Centre, Trivandrum

abdulshahidpp@gmail.com09946583120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026