| 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
|
|
|
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
|
|
|
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. |