Clincosm LogoSign in Get a demo

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

Sponsor
Grupo de Estudos Multicentricos em Onco-Hematologia (Other)
Overall Status
Completed
CT.gov ID
NCT03402295
Collaborator
(none)
311
Enrollment
2
Arms
100
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone
 Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
311 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Retrospectively compared two different groups of treatmentsRetrospectively compared two different groups of treatments
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jun 15, 2009
Actual Primary Completion Date :
Jun 15, 2014
Actual Study Completion Date :
Oct 15, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Grupo de Estudos Multicentricos em Onco-Hematologia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vania TM Hungria, Assintant Professor of Hematology oncology- Santa Casa de Sao Paulo Medical School, Grupo de Estudos Multicentricos em Onco-Hematologia
    ClinicalTrials.gov Identifier:
    NCT03402295
    Other Study ID Numbers:
    • GBRAM003r
    First Posted:
    Jan 18, 2018
    Last Update Posted:
    Jan 18, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Thalidomide
    Dexamethasone
    Cyclophosphamide
    Bortezomib

    Study Results

    No Results Posted as of Jan 18, 2018