Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Melphalan 140 mg/m2: Arm A Dose :140 mg/m2 Frequency: Single administration (one-time conditioning dose)
Route of Administration: Intravenous (IV) infusion via central venous catheter
Sponsors
ACTREC, Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: -Newly diagnosed Multiple Myeloma -Achieved a VGPR or deeper response prior to transplant within 12 weeks of transplant ECOG PS 0 to 2 -Acceptable liver functions, as specified below: Total bilirubin less than 3 times upper limit of normal ULN Aspartate transaminase AST SGOT, alanine transaminase ALT SGPT less than 5 ULN within two weeks of transplant -Acceptable hematological parameters: Hemoglobin more than 7 g per dl, Absolute neutrophil count ANC more than or equal to 500 per mm3, platelet count more than or equal to 50,000/mm3 within two weeks of transplant -Creatinine clearance more than or equal to 50 ml per minute by Cockgroft Gault formula within two weeks of transplant. -Undergoing a transplant between 6 to 12 cycles of induction Proteasome inhibitor Plus immunomodulatory drug plus or minus Daratumumab
Exclusion criteria
Exclusion criteria: -Other plasma cell dyscrasias AL Amyloidosis, POEMS syndrome -Patients undergoing or planned for tandem transplant -Patients with double hit any two high risk abnormalities or triple hit myeloma any three high risk abnormalities High risk abnormalities include - t(4 14), t(14 16), t(14 20), del17p, 1q gain or amplification and 1p deletion) -Patients with prior history or active symptomatic central nervous system involvement as per assessing clinician -New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction less than 40 percent -Human immunodeficiency virus (HIV) positive -Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the rate of BM MRD negativity at Day 100 (+ 30 days) following autologous stem cell transplant (ASCT).Timepoint: 14 weeks ( 4 weeks) post-ASCT | — |
Secondary
| Measure | Time frame |
|---|---|
| -Sustained BM MRD negativity at Day plus 100 & at 1 year 3 months plus or minus 15 days post ASCT -Acute toxicities associated with ASCT up to Day plus 30 post ASCT including incidence & duration of grade 3 to 4 mucositis TPN use gram negative infections duration of intravenous antibiotic use day of neutrophil & platelet engraftment number of PRBC & SDP units transfused & duration of hospitalization -Day plus 100 transplant related mortality -Concordance between PET CT MRD & bone marrow MRD prior to ASCT - Overall MRD negativity rate following ASCT - Two year progression free survival following ASCTTimepoint: -Approximately Week 14 & Week 65 plus minus 2 weeks post ASCT - Week 0 to Week 4 post ASCT - Up to approximately Week 14 post ASCT -Pre-transplant Baseline - Approximately Week 14 & Week 65 plus minus 2 weeks post ASCT - From Week 0 to Week 104 post ASCT | — |
Countries
India
Contacts
Public ContactDr Sumeet Mirgh
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre
Outcome results
None listed