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

Phase 3

Completed

• Conditions: Multiple Myeloma; Effects of Chemotherapy
• Interventions: Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone

• Registration Number: NCT03402295
• Lead Sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia

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.

Study Timeline

• Study Start: 2009-06-15
• Primary Completion: 2014-06-15
• Study Completion: 2017-10-15
• Study First Submitted: 2017-12-28
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Study First Posted: 2018-01-18
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ctd- Cyclophosphamide, thalidomide and dexamethasone	Bortezomib, cyclophosphamide, thalidomide, 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
Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)	Bortezomib, cyclophosphamide, thalidomide, 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

Primary Outcome Measures

Name	Time	Method
Response rate better than very good partial response after 4 induction cycles	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