| CTRI Number |
CTRI/2026/02/104902 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study Comparing High Dose and Lower Dose Melphalan Before Stem Cell Transplant for Multiple Myeloma |
|
Scientific Title of Study
|
Comparison of Melphalan 200 mg/m2 versus Melphalan 140 mg/m2 as Conditioning regimen in Newly Diagnosed Multiple Myeloma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Study Protocol Version 2.0 dated 19/01/2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumeet Mirgh |
| Designation |
Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Room no 307, BMT OPD, 3rd floor shanti sadan building Department of Medical Oncology Owe camp, Sector 22, ACTREC Advanced Centre for Training Research and Education in Cancer Kharghar navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
8130140245 |
| Fax |
|
| Email |
drsumeetmirgh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sumeet Mirgh |
| Designation |
Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Room no 307, BMT OPD, 3rd floor shanti sadan building Department of Medical Oncology Owe camp, Sector 22, ACTREC Advanced Centre for Training Research and Education in Cancer Kharghar navi Mumbai
MAHARASHTRA 410210 India |
| Phone |
8130140245 |
| Fax |
|
| Email |
drsumeetmirgh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sumeet Mirgh |
| Designation |
Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Room no 307, BMT OPD, 3rd floor shanti sadan building Department of Medical Oncology Owe camp, Sector 22, ACTREC Advanced Centre for Training Research and Education in Cancer Kharghar navi Mumbai
MAHARASHTRA 410210 India |
| Phone |
8130140245 |
| Fax |
|
| Email |
drsumeetmirgh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Both Intramural and Extramural 1) Intramural TRAC tata memorial hospital Address dr ernest borges marg parel mumbai 2) will apply Extramural LTMT and ICMR
|
|
|
Primary Sponsor
|
| Name |
ACTREC, Tata Memorial Centre |
| Address |
Owe camp, Sector 22, Kharghar, Navi Mumbai - 410210 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumeet Mirgh |
Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre |
Room no 307, BMT OPD, 3rd floor shanti sadan building Department of Medical Oncology Owe camp, Sector 22, Kharghar navi Mumbai
Raigarh MAHARASHTRA |
8130140245
drsumeetmirgh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C900||Multiple myeloma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 (tunnelled or non-tunnelled)
Preparation: Reconstituted in 0.9% Normal Saline to a maximum concentration of 1 mg/mL
Infusion Duration: Administered over approximately 30 minutes
Total Duration of Intervention: Single-day administration, followed by Peripheral Blood Stem Cell (PBSC) infusion 24 hours after melphalan administration |
| Comparator Agent |
Melphalan 200 mg/m² |
Arm B Dose Frequency: Melphalan 200 mg/m²
Single administration (one-time conditioning dose)
Route of Administration: Intravenous (IV) infusion via central venous catheter (tunnelled or non-tunnelled)
Preparation: Reconstituted in 0.9% Normal Saline to a maximum concentration of 1 mg/mL
Infusion Duration: Administered over approximately 30 minutes
Total Duration of Intervention: Single-day administration, followed by Peripheral Blood Stem Cell (PBSC) infusion 24 hours after melphalan administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-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
|
|
| ExclusionCriteria |
| Details |
-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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the rate of BM MRD negativity at Day 100 (+ 30 days) following autologous stem cell transplant (ASCT). |
14 weeks (± 4 weeks) post-ASCT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-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 ASCT |
-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 |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multiple Myeloma (MM) is a common blood cancer affects which accounts for 1.2% of cancers in India. The standard treatment for newly diagnosed patients with myeloma who can receive a transplant includes a combination of multiple medicines like Bortezomib, Lenalidomide, and Dexamethasone (VRd) with/without Daratumumab followed by stem-cell transplant and Lenalidomide maintenance. Transplant is a process which is commonly done after few cycles of chemotherapy when the cancer comes under control. For transplant, high doses of a chemotherapy medicine called melphalan is used. The standard dose of melphalan used for transplant is 200 mg/m², but a lower dose of 140 mg/m² is used for patients who are perceived to be at higher risk of complications. In today’s era, for assessing how much a cancer has come under control – a special test called minimal residual disease (MRD) is used. MRD means the least amount of cancer cells which are present in a patient’s body. It is known that in myeloma, patients who become MRD negative for their cancer have a better outcome in long run in contrast to others. This concept is similar to other blood cancers (like acute lymphoblastic leukemia) wherein MRD carries a lot of significance. The standard dose of melphalan was established two decades back when special tests like MRD were not available. In our practice, we have been doing MRD prior to transplant in all our myeloma patients who undergo transplant. Melphalan doses are reduced depending on patient’s clinical condition and organ functions prior to transplant. There is limited data comparing the outcomes of standard versus lower doses of melphalan, especially in today’s MRD era. We will address the above question in this prospective randomised study. We recently analysed our 15-year data of transplants and showed that lower dose of melphalan i.e., Mel-140 may be as equally effective as Mel-200 in people who respond well to initial treatment. Importantly, Mel-140, as compared to Mel-200 also has less side effects. In low-income nations like India, Mel-200 frequently commonly results in more severe side effects like severe mouth sores, deadly infections, and extended hospital admissions. A significant question which was brought up by our above study is that if Mel-200 is still the standard dose for all patients in the modern era of treatment? This study will test whether Mel-140 is just as effective as Mel-200 in patients who have already responded well to initial treatment (achieving what’s called a "very good partial response" or better). It will look at how many patients have no remaining signs of cancer (called MRD negativity) 100 days after transplant. MRD testing is commonly done from bone marrow in myeloma. Bone marrow is the factory in our body wherein commonly all healthy blood (including cells implicated in myeloma – called plasma cells) are made. Bone marrow testing means taking out a small amount of liquid from the hip bone for testing. Our study will compare MRD testing modality from bone marrow (which is the current accepted standard), and compare it with MRD test with other modalities (like a scan of the whole body called PET-CT). If this trial is successful, it may demonstrate that a lesser dose of chemotherapy is safer and effective for transplant in myeloma. Consequently, this would make transplantation less risky and easier, particularly for patients in low and middle-income nations like India |