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CTRI Number  CTRI/2025/01/079685 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Other 
Public Title of Study   Different stem cell collection protocols for multiple myeloma - Comparing their effectiveness 
Scientific Title of Study   Moving Beyond G-CSF mobilization - Learning from a 15-year Experience of Different Stem Cell Mobilization Regimens in Plasma cell Neoplasms 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol no 901095 Version 2.0 dated 07/01/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumeet Mirgh  
Designation  Associate Professor  
Affiliation  ACTREC TMC 
Address  Department of Medical Oncology Room no 305-306, BMT OPD, 3rd floor, Shanti Sadan OPD building, Owe camp, Sector 22, ACTREC Advanced Centre for Training, Research and Education in Cance

Raigarh
MAHARASHTRA
410210
India 
Phone  8130140245  
Fax    
Email  drsumeetmirgh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumeet Mirgh  
Designation  Associate Professor  
Affiliation  ACTREC TMC 
Address  Department of Medical Oncology Room no 305-306, BMT OPD, 3rd floor, Shanti Sadan OPD building, Owe camp, Sector 22, ACTREC Advanced Centre for Training, Research and Education in Cance

Raigarh
MAHARASHTRA
410210
India 
Phone  8130140245  
Fax    
Email  drsumeetmirgh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumeet Mirgh  
Designation  Associate Professor  
Affiliation  ACTREC TMC 
Address  Department of Medical Oncology Room no 305-306, BMT OPD, 3rd floor, Shanti Sadan OPD building, Owe camp, Sector 22, ACTREC Advanced Centre for Training, Research and Education in Cance

Raigarh
MAHARASHTRA
410210
India 
Phone  8130140245  
Fax    
Email  drsumeetmirgh@gmail.com  
 
Source of Monetary or Material Support  
Funding Not Applicable as this is a retrospective observational study Infrastructure support Advanced Centre for Treatment, Research and Education in Cancer Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210  
 
Primary Sponsor  
Name  ACTREC, Tata Memorial Centre 
Address  Owe camp, Sector 22, Kharghar, Navi Mumbai Raigarh 41021  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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   Department of Medical Oncology Room no 305-306, BMT OPD, 3rd floor, Shanti Sadan OPD building, Owe camp, Sector 22, ACTREC Advanced Centre for Training, Research and Education in Cancer
Raigarh
MAHARASHTRA 
8130140245

drsumeetmirgh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer Institutional Ethics Committee (TMC-IEC III)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E859||Amyloidosis, unspecified, (2) ICD-10 Condition: C900||Multiple myeloma, (3) ICD-10 Condition: C901||Plasma cell leukemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  -Diagnosis of plasma cell neoplasm multiple myeloma, AL amyloidosis, plasma cell leukemia or POEMS syndrome
-Patients who underwent peripheral blood stem cell collection
-Duration 1st September 2007 to 31st August 2024
 
 
ExclusionCriteria 
Details  Exclusion criteria
-Plasma cell neoplasms who did not undergo peripheral stem cell collection
-Those for whom stem cell mobilization was initiated but not completed and not undergone a stem cell harvest.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine proportion of patients with CD34+ dose more than or equal to 5x106/kg in first apheresis in various groups  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
-To determine total median CD34+ dose (x106/kg) of all harvests, in four groups
-Median CD34+ (x106/kg) in first apheresis, in four groups
-Incidence of mobilization failure in four groups (Mobilization failure will be defined as total CD34+ dose of less than 2x106/kg or abandoned harvest attempt anticipating a poor collection)
-Plerixafor subtraction analysis in groups 1, 3 and 4 (Analysis of patients who did not receive Plerixafor in groups 1,3 and 4, in order to study the inherent efficacy of a mobilization regimen, in the absence of plerixafor)
-Fold increment in CD34 between one day prior to mobilization and first day of apheresis, in four groups
-In patients who undergo autologous stem cell transplant in the above four groups –
-Incidence of engraftment syndrome
-Median progression-free survival
-Median overall survival
 
1 year 
 
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   N/A 
Date of First Enrollment (India)   07/02/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 is a blood cancer wherein abnormal proteins are produced from cancer cells and cause organ damage. After initial cancer control with chemotherapy, high dose chemotherapy and transplant is a common part of treatment in young patients. This helps in better control of cancer, as myeloma is considered incurable. For the process of transplant, stem cells are collected from blood, similar to the procedure of a regular blood donation in blood bank. Stem cells are parent cells in bone marrow which make all blood cells (red blood cells, white blood cells and platelets). Stem cells normally reside within the bone marrow. For ease of collection from the patient, we need to push them out from the bone marrow into blood. For collecting stem cells, multiple protocols are used. Common protocols have use of injections called “growth factors” which stimulate our stem cells to come out from bone marrow in blood, from where they can be collected easily. Other protocols use chemotherapy injections which creates a transient stress on the bone marrow. After few days, the bone marrow recovers from this stress, and in this process, a considerable number of stem cells are released into blood. Both the above procedures have the same common end-point of moving stem cells out from the bone marrow into blood, which enables their easy collection. There is no data from India which has compared the efficacy of chemotherapy-based protocols to growth-factor based protocols for stem cell collection from India. We wish to study this from our institute in patients with multiple myeloma. The above knowledge will help us understand appropriate benefits and drawbacks of these protocols in our setting, and thereby help future patients.

 
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