Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation (GBRAM003r)

January 17, 2018 updated by: Vania TM Hungria, Grupo de Estudos Multicentricos em Onco-Hematologia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)

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
Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone
Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)
Other Names:
  • Velcade, genuxal, decadron
Active Comparator: Ctd- Cyclophosphamide, thalidomide and dexamethasone

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate better than very good partial response after 4 induction cycles
Time Frame: Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Estudos Multicentricos em Onco-Hematologia

Investigators

  • Principal Investigator: Edvan Cusoe, MD, Federal University of Bahia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 15, 2009

Primary Completion (Actual)

June 15, 2014

Study Completion (Actual)

October 15, 2017

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBRAM003r

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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