| 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
|
|
|
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
|
|
|
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. |