A Phase 3 interventional study of Bortezomib, cyclophosphamide, thalidomide, dexamethasone in Multiple Myeloma and Effects of Chemotherapy, sponsored by Grupo de Estudos Multicentricos em Onco-Hematologia. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Grupo de Estudos Multicentricos em Onco-Hematologia · Phase 3, Interventional, and Treatment
This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.
The primary aim was observe response rate after 4 induction cycles.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 311 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Grupo de Estudos Multicentricos em Onco-Hematologia is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug pages: Bortezomib · Cyclophosphamide · Thalidomide · Dexamethasone
Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)
Also known as: Velcade, genuxal, decadron
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
Time frame: Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bortezomib · Cyclophosphamide · Thalidomide · Dexamethasone
Grupo de Estudos Multicentricos em Onco-Hematologia