Transplant-Ineligible Multiple Myeloma Patients Multiple Myeloma Transplant-Ineligible Lenalidomide Alternate-Day
Conditions
Interventions
Alternate-Day Lenalidomide,Daily Lenalidomide
Experimental Drug,Active Comparator Drug
Sponsors
Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Diagnosed with multiple myeloma 3. No planned autologous stem cell transplantation 4. Achieved at least partial response (PR) after induction therapy 5. Capable of informed consent and provision of written informed consent before any study procedures 6. Patients who cannot receive treatment with other methods or require lenalidomide as maintenance therapy but are unable to receive the medication due to financial constraints
Exclusion criteria
Exclusion criteria: 1. Ultra-high risk group includes patients diagnosed with plasma cell leukemia, Extramedullary plasmacytoma(s), multiple myeloma with at least 2 high-risk cytogenetic abnormalities including del(17p), TP53 mutation, gain/amp1q21, del(1p), t(4;14), t(14;16) or t(14;20) 2. Government employees/civil servants who achieved less than very good partial response (VGPR), as these patients are entitled to receive lenalidomide through their government healthcare benefits 3. Patients who have access to daratumumab maintenance therapy with ability to pay for the treatment costs themselves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T cell immune response D0, D30, D60, D90, D180, D270, Y1, Y1.5, Y2 after start Lenalidomide quantity of T cell | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate within 2 years evaluate from labouratory and imaging result,Progression free survival at progression of disease or death the time from maintenance to progression or death,Overall survival at death the time from maintenance to death,Adverse events within 2 years number of adverse event | — |
Countries
Thailand
Contacts
Public ContactChutima Kunacheewa
Faculty of Medicine Siriraj Hospital
Outcome results
None listed