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

Grupo de Estudos Multicentricos em Onco-Hematologia

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma; Effects of Chemotherapy

Treatments: Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03402295

GBRAM003r

Details and patient eligibility

About

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

Full description

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

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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311 participants in 2 patient groups

Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)

Active Comparator group

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

Treatment:

Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone

Ctd- Cyclophosphamide, thalidomide and dexamethasone

Active Comparator group

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

Treatment:

Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone