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

NCT03402295 | Completed Phase 3

• 1 other identifier: GBRAM003r
• Study Type: interventional
• Target: 311
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Myeloma; Effects of Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Response rate better than very good partial response after 4 induction cycles

  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

Study Arms (2)

Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)

ACTIVE COMPARATOR

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

Ctd- Cyclophosphamide, thalidomide and dexamethasone

ACTIVE COMPARATOR

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

Interventions

Bortezomib, cyclophosphamide, thalidomide, dexamethasone DRUG

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

Also known as: Velcade, genuxal, decadron

Ctd- Cyclophosphamide, thalidomide and dexamethasone; Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose \>18yo

You may not qualify if:

• other chemotherapy induction protocol

Sponsors & Collaborators

• Grupo de Estudos Multicentricos em Onco-Hematologia: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Cyclophosphamide; Thalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Edvan Cusoe, MD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assintant Professor of Hematology oncology- Santa Casa de Sao Paulo Medical School

Model Details: Retrospectively compared two different groups of treatments

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 18, 2018
• Study Start: June 15, 2009
• Primary Completion: June 15, 2014
• Study Completion: October 15, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share