Multiple MyelomaPhase 3GBRAM003rNCT03402295
Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation
A Phase 3 study testing Bortezomib, cyclophosphamide, thalidomide, dexamethasone in people with Multiple Myeloma and Effects of Chemotherapy, run by Grupo de Estudos Multicentricos em Onco-Hematologia.
Trial summary
This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Effects of Chemotherapy
- What is being tested?
- Bortezomib, cyclophosphamide, thalidomide, dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2009to 15 Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose >18yo
Who cannot join
- other chemotherapy induction protocol
About this study
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
This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.
Read the detailed description
The primary aim was observe response rate after 4 induction cycles.
- Conditions
- Multiple Myeloma, Effects of Chemotherapy
- Being tested
- Bortezomib, cyclophosphamide, thalidomide, dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib, cyclophosphamide, thalidomide, dexamethasoneDrug
Also called Velcade, genuxal, decadron
Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start15 Jun 2009
- Primary completion15 Jun 2014
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Retrospectively compared two different groups of treatments
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-Hematologia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Vania TM Hungria, Grupo de Estudos Multicentricos em Onco-Hematologia
- Investigators
- Edvan Cusoe, MD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402295
- Sponsor's protocol ID
- GBRAM003r
- Acronym
- GBRAM003r
- Status last verified
- Jan 2018
- First submitted
- 28 Dec 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03402295
- Acronym / sponsor ID
- GBRAM003r / GBRAM003r
- Conditions
- Multiple Myeloma, Effects of Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-HematologiaResearch network
- Study start
- 15 Jun 2009
- Primary completion
- 15 Jun 2014 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.
Detailed description
The primary aim was observe response rate after 4 induction cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Retrospectively compared two different groups of treatments
| Arm | Type | Receives |
|---|---|---|
| Vcd- (Bortezomibe, cyclophosphamide and dexamethasone) | Active comparator | Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasoneIntervention - 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 |
| Ctd- Cyclophosphamide, thalidomide and dexamethasone | Active comparator | Drug: Bortezomib, cyclophosphamide, thalidomide, dexamethasoneIntervention- 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose >18yo
Key exclusion criteria (1 listed)
- other chemotherapy induction protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib, cyclophosphamide, thalidomide, dexamethasoneAlso: Velcade, genuxal, decadronComparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida) | Drug | Ctd- Cyclophosphamide, thalidomide and dexamethasone, Vcd- (Bortezomibe, cyclophosphamide and dexamethasone) |
Primary outcome
Response rate better than very good partial response after 4 induction cycles
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edvan Cusoe, MD principal investigator
Federal University of Bahia
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bortezomib, cyclophosphamide, thalidomide, dexamethasone in people with Multiple Myeloma and Effects of Chemotherapy, run by Grupo de Estudos Multicentricos em Onco-Hematologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate better than very good partial response after 4 induction cycles (time frame: Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.