| CTRI Number |
CTRI/2019/09/021385 [Registered on: 23/09/2019] Trial Registered Prospectively |
| Last Modified On: |
24/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treament of multiple myeloma |
|
Scientific Title of Study
|
A phase II multicenter, randomized controlled trial comparing a generic triplet combination of Bortezomib-Pomalidomide-Dexamethasone vs Bortezomib-Lenalidomide –Dexamethasone in patients with newly diagnosed multiple myeloma |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anup Devasia |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no-09, Department of Haematology,
Christian Medical College,
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282352 |
| Fax |
04162226449 |
| Email |
dranupjdevasia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anup Devasia |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no-09, Department of Haematology,
Christian Medical College,
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282352 |
| Fax |
04162226449 |
| Email |
dranupjdevasia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anup Devasia |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no-09, Department of Haematology,
Christian Medical College,
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282352 |
| Fax |
04162226449 |
| Email |
dranupjdevasia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, Department of Haematology, Christian Medical College, Vellore, 632004, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Department of Haematology,
Christian Medical College,
Vellore |
| Type of Sponsor |
Other [Charitable trust hospital] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anup J Devasia |
Christian Medical College, Vellore |
Room no-09, Department of Haematology,
Christian Medical College,
Vellore
Vellore
TAMIL NADU |
04162282352
04162226449
dranupjdevasia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Silver |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bortezomib
Lenalidomide
Dexamethasone |
Inj. Bortezomib- 1.3mg/m2 on day1,8,15,22 x subcute x stat
Cap.Lenalidomide - 15mg x po x stat x 21/28
Tab.Dexamethasone-40mg x od x po x on day1, 8, 15, 22 |
| Intervention |
Bortezomib- Pomalidomide and Dexamethasone (VPD) |
Inj. Bortezomib- 1.3mg/m2 on day1,8,15,22 x subcute x stat
Cap.Pomalidomide - 4mg x od x pox 21/28
Tab. Dexamethasone-40mg x od x po x on day1, 8, 15, 22 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)Newly diagnosed patients with multiple myeloma
b)Age between 18-60years
|
|
| ExclusionCriteria |
| Details |
a)Creatinine clearance <30 or patients on dialysis
b)Venous thromboembolism at diagnosis
c)Past history of venous thromboembolism
d)Hepatic dysfunction – Bil > 2, AST/ALT >4 times ULN
e)Grade 3-4 peripheral neuropathy
f)Pregnancy
g)Not able to understand the investigative nature of the study or give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Complete response after 4 cycles of therapy
|
4 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a.Overall response rates after 4 cycles
b.MRD (minimal residual disease) negativity after 4 cycles
c.Three-year event free survival
d.Three-year overall survival
e.The incidence of grade 3 and 4 adverse events
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/09/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The results of this study will be published in reputed National and International Journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Newly diagnosed patients with multiple myeloma who are
eligible for the study will be randomized into 2 arms. Patients in the first
arm will be given a triplet induction – VPD
(Bortezomib-Pomalidomide-Dexamethasone) for 4 cycles. Transplant eligible
patients would undergo an autologous stem cell transplantation after 4 cycles
and post transplantation would be started on Pomalidomide as maintenance which
will be continued for 2 years. Transplant ineligible patients will be put on
Pomalidomide maintenance for 2 years.
Patients in the second arm will be given a triplet induction –
VLD (Bortezomib-lenalidomide-Dexamethasone) for 4 cycles. Transplant eligible
patients would undergo an autologous stem cell transplantation after 4 cycles
and post transplantation would be started on lenalidomide as maintenance which
will be continued for 2 years. Transplant ineligible patients will be put on
Lenalidomide maintenance for 2 years.
Patients in these 2 groups will be followed up for a minimum
of 3 years and will be compared for difference in achievement of complete
response after 4 cycles of induction, event free survival, overall survival,
time to next therapy and complications.
Introduction: A triplet based induction regimen containing a
proteasome inhibitor and an immunomodulatory is considered the standard of care
induction regimen for newly diagnosed patients with multiple myeloma.
Pomalidomide is the newest immunomodulatory agent and has shown significant
anti-myeloma activity and response rates in relapsed and refractory myeloma.
However, Pomalidomide has never been tried in the upfront treatment of multiple
myeloma.
Aims and objectives: To compare the effect of a triplet
combination of Bortezomib-Pomalidomide-Dexamethasone vs Bortezomib-Lenalidomide
–Dexamethasone in patients with newly diagnosed multiple myeloma.
Methodology: Eligible patients newly diagnosed multiple
myeloma patients will be randomly assigned into 2 groups. One group will receive a triplet regimen
containing Bortezomib- Pomalidomide and Dexamethasone (VPD). The other group will
receive Bortezomib-lenalidomide-Dexamethasone (VLD) regimen. The patients in
the 2 groups will be analyzed for clinical response at the end of 4 cycles.
At the end of 4 cycles, if patients attain more than very good
partial response, all transplant eligible patients would be offered an
autologous stem cell transplantation. In either of the groups, patients
undergoing the autologous stem cell harvest would be given maintenance with the
immunomodulatory (Pomalidomide or Lenalidomide) given during induction. The
enrollment will be for 2 years. All
patients will be followed up for a minimum period of 3 years and they will be
evaluated for 3-year event free survival, overall survival, and grade 3 and 4 toxicity.
Each centre will recruit 40-50 patients for this study.
|