| CTRI Number |
CTRI/2025/01/079150 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Home-Based Subcutaneous Bortezomib for Patients with Multiple Myeloma and Amyloidosis |
|
Scientific Title of Study
|
A Phase II Prospective clinical trial in patients with Multiple Myeloma and Amyloidosis: Evaluating Feasibility of home Administered Subcutaneous Bortezomib Injections. |
| Trial Acronym |
SABIMA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhausaheb Bagal |
| Designation |
Professor and Consultant |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Centre,
Department of Adult Hematolymphoid- Medical Oncology
Dr Ernest Borges Road, Parel,
Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177210 |
| Fax |
|
| Email |
bagalbp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhausaheb Bagal |
| Designation |
Professor and Consultant |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Centre,
Department of Adult Hematolymphoid- Medical Oncology
Dr Ernest Borges Road, Parel,
Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177210 |
| Fax |
|
| Email |
bagalbp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhausaheb Bagal |
| Designation |
Professor and Consultant |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Centre,
Department of Adult Hematolymphoid- Medical Oncology
Dr Ernest Borges Road, Parel,
Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177210 |
| Fax |
|
| Email |
bagalbp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Grant of Tata memorial Centre of Mumbai, Dr Ernest Borges Road, Parel,
Mumbai, Maharashtra 400012 |
|
|
Primary Sponsor
|
| Name |
TRAC |
| Address |
CRS department, 3rd floor, main building, Tata Memorial Centre, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhausaheb Bagal |
ACTREC |
Department of Adult Hematolymphoid- Medical Oncology, Sector-22, Kharghar, Navi Mumbai. 410210
Thane
MAHARASHTRA |
02224177210
bagalbp@gmail.com |
| Dr Bhausaheb Bagal |
Tata Memorial Centre |
Department of Adult Hematolymphoid- Medical Oncology, Dr Ernest Borges Road, Parel,
Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA |
02224177210
bagalbp@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
home-administered subcutaneous Bortezomib injections. |
The intervention in this study would be home-administered subcutaneous Bortezomib injections. Typically, Bortezomib is given intravenously or subcutaneously in clinical settings, but this trial is focused on evaluating the feasibility of patients administering the medication at home.
Dose, frequency and duration -1.3 mg/m2 every week for 4 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with Multiple Myeloma and Amyloidosis (Confirmed with : Bone
marrow biopsy, blood reports?)
At baseline normal hematological parameters :
1. Absolute neutrophil count (ANC) ≥ 1.5 × 10â¹/L,
2. Platelet count ≥ 100 ×10â¹/L, and
3. Hemoglobin ≥ 8 g/dL (may have been transfused)
Patient willing to give consent. |
|
| ExclusionCriteria |
| Details |
Pregnant or nursing woman.
Inability to understand the written and verbal instructions.
Not willing for follow-up as per the protocol.
Skin disease hampering subcutaneous administration
Seropositivity for HIV, HBsAg or HCV. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Variables to be estimated Percentage of patients with self administer bortezomib and incidence of grade 3 or more side effects |
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety(Grade 3 side effects) over the course of study. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/02/2025 |
| 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="2"
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
|
This is a Phase 2 study evaluating the feasibility and safety of self-administered subcutaneous bortezomib injections at home in patients diagnosed with multiple myeloma and amyloidosis. Primary endpoint is Feasibility of self-administered Bortezomib injection at home, assessed by adherence to the self administration regimen, safety outcomes, and patient satisfaction & Proportion of participants achieving a Relative Dose Intensity(RDI) of Bortezomib surpassing the predetermined threshold of 80%. Secondary Endpoint is Incidence and severity of adverse events such as injection site reactions, systemic reactions, and other treatment-related complications associated with self-administered subcutaneous bortezomib injections at home & Treatment adherence and persistence (Proportion of doses note self administered, Treatment interruptions, Discontinuations of self administration) |