Multiple MyelomaPhase 3NCT01296503
Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma
A Phase 3 study testing Thalidomide plus dexamethasone and Dexamethasone in people with Multiple Myeloma, run by Grupo de Estudos Multicentricos em Onco-Hematologia at 4 sites in Brazil.
Trial summary
This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Thalidomide plus dexamethasone and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 4 sitesBrazil
- Study dates
- Oct 2003to Dec 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic multiple myeloma in accordance with the International Myeloma Working Group criteria;
- age 18-70 years;
- Performance status 0-2 by the Eastern Cooperative Oncology Group (ECOG) criteria;
- normal hepatic function, defined as serum bilirubin <3 mg/dl and alanine aminotransferase(ALT) and asparagin aminotransferase (AST) <4x normal.
Who cannot join
- evidence of disease progression after ASCT;
- cardiac dysfunction (systolic ejection fraction <50%);
- chronic respiratory disease (carbon monoxide diffusion <50% of normal).
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Universidade Estadual de Campinas
Campinas, São Paulo
Universidade de São Paulo- Ribeirão Preto
Ribeirão Preto, São Paulo
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 21941913
Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo
About this study
Official title: Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial
This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.
Read the detailed description
Patients were recruited prior to receiving induction therapy, and randomization in a 1:1 ratio occurred on day 60 post-autologous stem cell transplantation. The treatment consisted of the following four phases:
- induction with 3-5 cycles of vincristine plus doxorrubicin and dexamethasone (VAD) every 21-28 days: vincristine 0.4 mg , doxorubicin 9 mg/m² and oral dexamethasone 40 mg daily for 4 days;
- cyclophosphamide (4 g/m2 ) plus filgrastim (G-CSF) (5 μg/kg twice a day) for stem cell mobilization;
- melphalan (200 mg/m2 ) and one autologous stem cell transplant (ASCT);
- Sixty days (D +60) after ASCT: RANDOMIZATION in two arms of maintenance: Arm A (oral dexamethasone alone 40 mg/d for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg daily by mouth) for 12 months or until disease progression.
- Conditions
- Multiple Myeloma
- Being tested
- Thalidomide plus dexamethasone, Dexamethasone
- Keywords
- Multiple Myeloma, Treatment, Maintenance, Thalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide plus dexamethasoneDrug
Also called Thalomid, Baycadron, DexPak, Decadron
D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression.
The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.
DexamethasoneDrug
Also called Baycadron, DexPak, Decadron
dexamethasone alone 40 mg/day for 4 days every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone (Arm A) | Active comparator | Sixty days (D+60) after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) Receives: Drug: Dexamethasone |
| Thalidomide and Dexamethasone (Arm B) | Experimental | D+60 after ASCT: dexamethasone plus thalidomide 200 mg by mouth daily for 12 months or until disease progression.
The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event. Receives: Drug: Thalidomide plus dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free survival
Primary endpoint: progression free survival (PFS) PFS was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
Measured: 36 months
Secondary outcomes (2)
Overall survival
Secondary endpoints: overall survival (OS) was defined as the interval from randomization to death (or the last follow-up for surviving patients). For patients who were not randomized, OS was calculated from the date of diagnosis until the date of death or last follow-up.
Measured: 36 months
safety of thalidomide
The number of patients experiencing adverse events grade 3 or 4 were compared between treatment arms. Adverse events were classified as defined by the National Cancer Institute Common Toxicity Criteria, version 2. Safety evaluations were focused especially on neurological symptoms and the development of deep venous thrombosis (DVT). Adverse events evaluations were performed at the time of response assessment and whenever a new clinical manifestation suggestive of toxicity appeared.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startOct 2003
- Primary completionJul 2008
- Study completionDec 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-Hematologia
- Sponsor type
- Research network
- Investigators
- Angelo Maiolino, MD, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296503
- Sponsor's protocol ID
- GBRAM0001
- Status last verified
- Feb 2011
- First submitted
- 27 Jan 2011
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial
- ClinicalTrials.gov ID
- NCT01296503
- Acronym / sponsor ID
- GBRAM0001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Treatment, Maintenance, Thalidomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-HematologiaResearch network
- Study start
- Oct 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Feb 2011 (estimated)
- 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 multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.
Detailed description
Patients were recruited prior to receiving induction therapy, and randomization in a 1:1 ratio occurred on day 60 post-autologous stem cell transplantation. The treatment consisted of the following four phases:
- induction with 3-5 cycles of vincristine plus doxorrubicin and dexamethasone (VAD) every 21-28 days: vincristine 0.4 mg , doxorubicin 9 mg/m² and oral dexamethasone 40 mg daily for 4 days;
- cyclophosphamide (4 g/m2 ) plus filgrastim (G-CSF) (5 μg/kg twice a day) for stem cell mobilization;
- melphalan (200 mg/m2 ) and one autologous stem cell transplant (ASCT);
- Sixty days (D +60) after ASCT: RANDOMIZATION in two arms of maintenance: Arm A (oral dexamethasone alone 40 mg/d for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg daily by mouth) for 12 months or until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone (Arm A) | Active comparator | Drug: DexamethasoneSixty days (D+60) after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) |
| Thalidomide and Dexamethasone (Arm B) | Experimental | Drug: Thalidomide plus dexamethasoneD+60 after ASCT: dexamethasone plus thalidomide 200 mg by mouth daily for 12 months or until disease progression. The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic multiple myeloma in accordance with the International Myeloma Working Group criteria;
- age 18-70 years;
- Performance status 0-2 by the Eastern Cooperative Oncology Group (ECOG) criteria;
- normal hepatic function, defined as serum bilirubin <3 mg/dl and alanine aminotransferase(ALT) and asparagin aminotransferase (AST) <4x normal.
Key exclusion criteria (3 listed)
- evidence of disease progression after ASCT;
- cardiac dysfunction (systolic ejection fraction <50%);
- chronic respiratory disease (carbon monoxide diffusion <50% of normal).
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 |
|---|---|---|
| Thalidomide plus dexamethasoneAlso: Thalomid, Baycadron, DexPak, DecadronD+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression. The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event. | Drug | Thalidomide and Dexamethasone (Arm B) |
| DexamethasoneAlso: Baycadron, DexPak, Decadrondexamethasone alone 40 mg/day for 4 days every 28 days | Drug | Dexamethasone (Arm A) |
Primary outcome
Progression Free survival
Time frame: 36 months
Primary endpoint: progression free survival (PFS) PFS was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
2 secondary outcomes
Overall survival
Time frame: 36 months
safety of thalidomide
Time frame: 36 months
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 15 Feb 2011.
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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.
Angelo Maiolino, MD, PhD principal investigator
Universidade Federal do Rio de Janeiro
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thalidomide plus dexamethasone and Dexamethasone in people with Multiple Myeloma, run by Grupo de Estudos Multicentricos em Onco-Hematologia at 4 sites in Brazil.
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 4 inclusion and 3 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 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Progression Free survival (time frame: 36 months). 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 15 Feb 2011.