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

Study Overview
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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.

Official Title
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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

Conditions
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Multiple Myeloma, Effects of Chemotherapy

Intervention / Treatment
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* Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Retrospectively compared two different groups of treatments
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)<br>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<br>* Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)<br>* Other names: Velcade, genuxal, decadron;|
| Active Comparator: Ctd- Cyclophosphamide, thalidomide and dexamethasone<br>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<br>* Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)<br>* Other names: Velcade, genuxal, decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |