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

NCT ID: NCT03402295

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-15

Study Completion Date

2017-10-15

Brief Summary

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

Detailed Description

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

Conditions

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Multiple Myeloma Effects of Chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Retrospectively compared two different groups of treatments
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Bortezomib, cyclophosphamide, thalidomide, dexamethasone

Intervention Type DRUG

Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)

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

Group Type ACTIVE_COMPARATOR

Bortezomib, cyclophosphamide, thalidomide, dexamethasone

Intervention Type DRUG

Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)

Interventions

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Bortezomib, cyclophosphamide, thalidomide, dexamethasone

Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)

Intervention Type DRUG

Other Intervention Names

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Velcade, genuxal, decadron

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo de Estudos Multicentricos em Onco-Hematologia

NETWORK

Sponsor Role lead

Responsible Party

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Vania TM Hungria

Assintant Professor of Hematology oncology- Santa Casa de Sao Paulo Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edvan Cusoe, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Other Identifiers

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GBRAM003r

Identifier Type: -

Identifier Source: org_study_id

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