Back to resultsSuperiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation (GBRAM003r)
Primary Purpose
Multiple Myeloma, Effects of Chemotherapy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bortezomib, cyclophosphamide, thalidomide, dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose >18yo
Exclusion Criteria:
- other chemotherapy induction protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)
Ctd- Cyclophosphamide, thalidomide and dexamethasone
Arm Description
Intervention - Bortezomib 1.3mg/m2 Intra venous or Subcutaneous once a week (D1-8-15-22) 35days cycle Intervention- Dexamethasone 40mg once a week for four weeks orally or Intravenously- total dose per cycle was 160mg. Intervention- Cyclophosphamide 900-2000mg- intravenously or orally- total dose monthly Total of four cycles
Intervention- Cyclophosphamide 900-2000mg intravenously or orally total dose monthly Intervention- Thalidomide 100-200mg orally- daily dose Intervention -Dexamethasone 40mg once a week for four weeks each month- total dose per cycle was 160mg Total of four cycles (cycles of 28 each one) 28 days each cycles- total of four cycles
Outcomes
Primary Outcome Measures
Response rate better than very good partial response after 4 induction cycles
The primary outcome is to observe the difference response rate between VCD and CTD induction myeloma elegible patient
Secondary Outcome Measures
Full Information
NCT ID
NCT03402295
First Posted
December 28, 2017
Last Updated
January 17, 2018
Sponsor
Grupo de Estudos Multicentricos em Onco-Hematologia
1. Study Identification
Unique Protocol Identification Number
NCT03402295
Brief Title
Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation
Acronym
GBRAM003r
Official Title
Superiority of the Triple Combinations of Bortezomib, Cyclophosphamide and Dexamethasone (VCD) Versus Cyclophosphamide, Thalidomide and Dexamethasone (CTD) in Patients With Newly Diagnose Multiple Myeloma, Eligible for Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2009 (undefined)
Primary Completion Date
June 15, 2014 (Actual)
Study Completion Date
October 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo de Estudos Multicentricos em Onco-Hematologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.
Detailed Description
The primary aim was observe response rate after 4 induction cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Effects of Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Retrospectively compared two different groups of treatments
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)
Arm Type
Active Comparator
Arm Description
Intervention - Bortezomib 1.3mg/m2 Intra venous or Subcutaneous once a week (D1-8-15-22) 35days cycle Intervention- Dexamethasone 40mg once a week for four weeks orally or Intravenously- total dose per cycle was 160mg.
Intervention- Cyclophosphamide 900-2000mg- intravenously or orally- total dose monthly Total of four cycles
Arm Title
Ctd- Cyclophosphamide, thalidomide and dexamethasone
Arm Type
Active Comparator
Arm Description
Intervention- Cyclophosphamide 900-2000mg intravenously or orally total dose monthly Intervention- Thalidomide 100-200mg orally- daily dose Intervention -Dexamethasone 40mg once a week for four weeks each month- total dose per cycle was 160mg Total of four cycles (cycles of 28 each one)
28 days each cycles- total of four cycles
Intervention Type
Drug
Intervention Name(s)
Bortezomib, cyclophosphamide, thalidomide, dexamethasone
Other Intervention Name(s)
Velcade, genuxal, decadron
Intervention Description
Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)
Primary Outcome Measure Information:
Title
Response rate better than very good partial response after 4 induction cycles
Description
The primary outcome is to observe the difference response rate between VCD and CTD induction myeloma elegible patient
Time Frame
Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose >18yo
Exclusion Criteria:
other chemotherapy induction protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edvan Cusoe, MD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation
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