FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066154 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 19/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective observational study 
Study Design  Other 
Public Title of Study   To study the outcomes of Multiple Myeloma patients who developed a relapse after transplant  
Scientific Title of Study   Retrospective Analysis of Outcome and Survival of Patients with Multiple Myeloma who Relapse post Autologous Stem Cell Transplant  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol no 901042 Version 1.0 dated 14.12.2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumeet Mirgh  
Designation  Associate Professor  
Affiliation  Tata Memorial Centre ACTREC (Advanced Centre for Treatment, Research and Education in Cancer)  
Address  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), Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  8130140245  
Fax    
Email  drsumeetmirgh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arti Goel 
Designation  Senior resident II  
Affiliation  Tata Memorial Centre ACTREC (Advanced Centre for Treatment, Research and Education in Cancer)  
Address  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), Kharghar, Navi Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9712195645  
Fax    
Email  aartigoel309@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arti Goel 
Designation  Senior resident II  
Affiliation  Tata Memorial Centre ACTREC (Advanced Centre for Treatment, Research and Education in Cancer)  
Address  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), Kharghar, Navi Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9712195645  
Fax    
Email  aartigoel309@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  Advanced Centre for Training, Research and Education in Cancer 
Address  Owe camp, Sector 22, Kharghar, Navi Mumbai Raigarh 41021 
Type of Sponsor  Research institution and hospital 
 
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), Kharghar, Navi Mumbai
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: C900||Multiple myeloma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  not applicable  not applicable 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -Patients of Multiple myeloma who have undergone ASCT
-Patients who have relapsed post ASCT
 
 
ExclusionCriteria 
Details  -Other plasma cell dyscrasias who undergo ASCT (like AL amyloidosis, POEMS syndrome etc) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
- Response rates with first salvage regimen in Multiple myeloma patients who relapse post ASCT
- PFS-2 rates with different salvage regimens in Multiple myeloma
 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
-Incidence of relapse or progression post ASCT
-Time to relapse or progression post ASCT
-PFS-1 post ASCT in standard versus high-risk Multiple myeloma
-Overall Survival in Multiple Myeloma patients who relapse post ASCT
-Median time to start of first salvage post ASCT
-Median number of relapses or progression post ASCT
-Median number of salvage therapies given post ASCT 
1 year 
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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)   07/05/2024 
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 (MM) is the prototype of all plasma cell dyscrasias. It is the second most common hematological malignancy with increasing incidence across the world. Induction therapy with a triplet [incorporating a proteasome inhibitor (Bortezomib), immunomodulatory drug (lenalidomide), and steroid (dexamethasone)] or quadruplet [triplet + monoclonal antibody (daratumumab)] regimen is the standard upfront treatment. After 4-6 cycles of induction, high dose melphalan followed by autologous stem cell rescue / transplant (ASCT) is the standard treatment in young and fit patients with this disease. ASCT results in increased CR rates, prolongs progression free survival and can cure a fraction of patients. The role of ASCT for prolonging disease-free survival remains even in the era of novel agents and long term lenalidomide maintenance. In contrast to our western counterparts, the median age of MM patients in India is a decade younger i.e., in 4th -5th decade. 

MM accounts for 20% of all hematopoietic stem cell transplants and approximately 50% of all autologous transplants done in India. Across major studies of ASCT from India, 5-year disease free survival varies from 35-55% [1]. This means that atleast 50-60% MM patients relapse within 5 years of ASCT in India. As per International Myeloma Working group (IMWG) guidelines, a relapse of MM is defined as recurrence of disease after prior response on the basis of objective laboratory and radiological criteria. It includes either of the following - ≥25% increase of the monoclonal protein (M-protein) in serum (absolute increase ≥ 0.5 g/dL) or urine (absolute increase ≥ 200 mg/d) or ≥25% difference between involved and uninvolved serum-free light chains (absolute increase > 10 mg/dL) or >10% increase of the absolute percentage of bone marrow plasma cells or development of new (extramedullary) plasmacytomas or hypercalcemia. Similarly, relapsed/refractory MM (RRMM) is defined as disease that becomes nonresponsive or progressive on therapy or within 60 days of last treatment in patients who had achieved a minimal response or better on prior therapy. 

The decision to treat a patient who has relapsed post ASCT will depend on the type of relapse (biochemical versus clinical). Moreover, the treatment for a post ASCT relapse will also be dictated by multiple factors – comorbidities, duration of response to first line treatment or ASCT, refractoriness to prior therapy, presence of any extramedullary disease or high-risk cytogenetics at relapse. The French group have reported that early relapse (within 18 months of initial diagnosis which equates to within 12 months of ASCT) is a poor prognostic factor post ASCT, irrespective of cytogenetic risk. Data available from randomised clinical trials (RCTs) have shown that while treating at relapse, triplets should be preferred and continuous treatment or maintenance prolongs PFS. Following triplet regimens have shown improvement in survival in RCTs which included 50-60% subjects with prior ASCT – KRd (Carfilzomib-Lenalidomide-dexamethasone), DRd (Daratumumab-Lenalidomide-dexamethasone), Elo-Rd (Elotuzumab-Lenalidomide-dexamethasone), Ixa-Rd (Ixazomib-Lenalidomide-dexamathasone), DVd (Daratumumab-Bortezomib-dexamethasone), VPd (Bortezomib-Pomalidomide-dexamethasone), DKd (Daratumumab-carfilzomib-dexamethasone), SVd (Selenexor-Bortezomib-dexamethasone). However, in majority of patients, it is not possible to use daratumumab owing to its exorbitant costs, and carfilzomib too due to its cardiotoxicity, need for weekly intravenous infusions and financial burden in long term. There is paucity of data from India pertaining to outcomes and survival of post ASCT relapses in MM. Hence, it would be prudent to know the response rates and outcomes with various treatment regimens given for post ASCT relapses.
 
Close