multiple myeloma Del (17p) TP53 mutation multiple myeloma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals who are 18 years old or older 2. Diagnosed with active myeloma according to 2014 IMWG criteria 3. Patient must have measurable disease (quantifiable serum or urine M-protein) on diagnosis (defined as serum M protein more than or equal 0.5 g/dL or 24-hour urine M-protein excretion more than or equal 200mg or dFLC more than or equal 10 mg/dL (more than or equal 100 mg/L) or an abnormal serum free light chain ratio ( less than 0.26 or more than 1.65) 4. Documented del (17p) and/or TP53 mutation based on laboratory testing (e.g., FISH and/or NGS)
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with symptomatic amyloidosis, Waldenstrom macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients enrolled in clinical trials during any time point of their treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate after each line of therapy during follow up Proportion of patients achieving partial response or better,Duration of Response From first documented response until progression death or last follow up Time from first achievement of partial response or better to disease progression or death,Progression Free Survival From diagnosis until progression Time from date of diagnosis to disease progression,Overall Survival From diagnosis until death ime from date of diagnosis to death | — |
Secondary
| Measure | Time frame |
|---|---|
| Risk factors for Overall Survival From diagnosis until death or last follow up Association between baseline clinical cytogenetic and treatment related factors and overall survival,Minimal Residual Disease Negativity Rate Post treatment at documented response assessment Proportion of patients achieving MRD negativity,PET CT Response Post treatment at time of PET CT assessment Proportion of patients achieving metabolic response on PET CT | — |
Countries
Thailand
Contacts
Faculty of Medicine Siriraj Hospital