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NCT03402295 Clinical Trial

Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation

Multiple Myeloma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03402295
Other study ID # GBRAM003r
Secondary ID
Status Completed
Phase Phase 3
First received December 28, 2017
Last updated January 17, 2018
Start date June 15, 2009
Est. completion date October 15, 2017

Study information
Verified date January 2018
Source Grupo de Estudos Multicentricos em Onco-Hematologia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.

Description:

The primary aim was observe response rate after 4 induction cycles.

Recruitment information / eligibility
Status Completed
Enrollment 311
Est. completion date October 15, 2017
Est. primary completion date June 15, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bortezomib, cyclophosphamide, thalidomide, dexamethasone
Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Grupo de Estudos Multicentricos em Onco-Hematologia

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion
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