Multiple MyelomaPhase 3NCT01532856
Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
A Phase 3 study testing Thalidomide, Cyclophosphamide, Dexamethasone, Thalidomide, Dexamethasone and Thalidomide, Melphalan, Prednisone in people with Multiple Myeloma, run by Grupo de Estudos Multicentricos em Onco-Hematologia at 3 sites in Brazil.
Trial summary
This protocol is an international, multicenter, comparative, open and randomized study designed to compare the safety and efficacy (in terms of response rate) from three induction chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Thalidomide, Cyclophosphamide, Dexamethasone, Thalidomide, Dexamethasone and Thalidomide, Melphalan, Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2007to Jun 2012
- 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
- > 65 years old and non candidate for autologous stem cell transplant
- Patient must be newly diagnosed with Multiple Myeloma according to establish criteria symptoms. Steroid pulses administration are allowed for any required emergency prior to starting induction therapy or bisphosphonates administration
- Patient must have measurable disease, defined as follows: for secretory multiple myeloma, measurable disease is defined by the presence of measurable monoclonal component in serum or in urine excretion if light chain is greater than or equal to 200 mg/24 hours(Annex 5)
- Measured ECOG < 2 state level.
- The patient must have a life expectancy greater than 3 months.
- Adequate laboratory values prior to induction treatment initiation, defined as follow:
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- Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g / dl and absolute neutrophil count ≥ 1000/mm3. Lower values are permitted if they are due to BM infiltration.
- Corrected serum calcium ≤ 14mg/dl.
- Aspartate transaminase (AST): ≤ 2.5 x normal upper limit.
- Alanine transaminase (ALT):): ≤ 2.5 x normal upper limit.
- Total bilirubin: ≤ 1.5 x normal upper limit.
- Serum creatinine ≤ 2 mg / dl.
- Men (including vasectomy done) must use barrier contraception (latex condoms) when having sex with women of potential childbearing, and for at least four weeks after thalidomide last dose.
Who cannot join
- Non-secretory MM.
- Previous treatment for multiple myeloma with the exception of steroid pulses for any emergency that requires treatment before beginning the induction, administration of bisphosphonates or radiation therapy.
- Basal peripheral neuropathy higher than grade 2 within 14 days of inclusion.
- Known thalidomide hypersensitivity.
- Use of any investigational agent within 30 days prior to their inclusion.
- Known human immunodeficiency virus(HIV) infection, detectable surface antigen of hepatitis B or active infection by the hepatitis C viruses
- Myocardial infarction within 6 months prior to inclusion or heart functional class III or IV according to New York Heart Association (NYHA) heart failure, angina, uncontrolled ventricular arrhythmias or acute ischemia detected by electrocardiogram or conduction system abnormalities.
- Participation in another clinical trial or receiving any investigational agent.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro
Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo
About this study
Official title: Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maintenance Therapy With Thalidomide + Prednisone Versus Thalidomide Alone in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65years.
This protocol is an international, multicenter, comparative, open and randomized study designed to compare the safety and efficacy (in terms of response rate) from three induction chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is also designed to compare the safety and efficacy (in terms of duration of response) of two maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each treatment arm will include 100 patients and assessments and scheduled visits will be conducted in three periods: Pre-treatment, treatment and monitoring. Security will be evaluated by monitoring all adverse events, physical examination, vital signs and biochemical studies. Response to treatment will be evaluated according to the EBMT21 criteria and will be assessed on day 1 of each cycle of induction, at the end of nine cycles of induction therapy and monthly during the first year of maintenance therapy and every 3 months thereafter.
- Conditions
- Multiple Myeloma
- Being tested
- Thalidomide, Cyclophosphamide, Dexamethasone, Thalidomide, Dexamethasone, Thalidomide, Melphalan, Prednisone
- Keywords
- multiple myeloma, thalidomide, comparative, elderly
- 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, Cyclophosphamide, DexamethasoneDrug
Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Cyclophosphamide - 50mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally(two pulses the first two cycles in days 1-4 and 15-18 and then a single pulse in each other cycle) during 9 cycles of 28 days.
Thalidomide, DexamethasoneDrug
Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally, in three pulses (days 1 to 4, 9 to 12 and 17 20) odd cycles and a single pulse treatment in pairs cycles, during 9 cycles of 28 days each cycle
Thalidomide, Melphalan, PrednisoneDrug
thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle; melphalan - 4 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle; prednisone - 40 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle
| Study group | Role | What they receive |
|---|---|---|
| Group A induction therapy | Active comparator | Thalidomide + Cyclophosphamide + Dexamethasone Receives: Drug: Thalidomide, Cyclophosphamide, Dexamethasone |
| Group B induction therapy | Active comparator | thalidomide + dexamethasone Receives: Drug: Thalidomide, Dexamethasone |
| Group C induction therapy | Active comparator | thalidomide + melphalan + prednisone Receives: Drug: Thalidomide, Melphalan, Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response rate is evaluated between the 3 treatment arms
Measured: 36 months
Duration of response
Duration of response was defined as the time to the first evidence of laboratorisl progreesion.
Measured: 36 months
Secondary outcomes (3)
overall survival
Overall survival (OS) was defined as the interval from randomization to death or the last follow-up for surviving patients.
Measured: 36 months
event-free survival
Event-free survival was defined as the interval from randomization to any event (death or descontinuation due to protocol violation or non-acceptable toxicities)
Measured: 36 months
progression free-survival
Progression free-survival was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
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 2012 (estimated)
- Study startJan 2007
- Primary completionDec 2011
- Study completionJun 2012 (estimated)
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-Hematologia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vania Hungria, PhD MD, Principal investigator, Santa Casa de Misericordia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532856
- Sponsor's protocol ID
- GBRAM0002
- Status last verified
- Feb 2012
- First submitted
- 10 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maintenance Therapy With Thalidomide + Prednisone Versus Thalidomide Alone in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65years.
- ClinicalTrials.gov ID
- NCT01532856
- Acronym / sponsor ID
- GBRAM0002
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, thalidomide, comparative, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-HematologiaResearch network
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (estimated)
- First posted
- 15 Feb 2012 (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 protocol is an international, multicenter, comparative, open and randomized study designed to compare the safety and efficacy (in terms of response rate) from three induction chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is also designed to compare the safety and efficacy (in terms of duration of response) of two maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each treatment arm will include 100 patients and assessments and scheduled visits will be conducted in three periods: Pre-treatment, treatment and monitoring. Security will be evaluated by monitoring all adverse events, physical examination, vital signs and biochemical studies. Response to treatment will be evaluated according to the EBMT21 criteria and will be assessed on day 1 of each cycle of induction, at the end of nine cycles of induction therapy and monthly during the first year of maintenance therapy and every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A induction therapy | Active comparator | Drug: Thalidomide, Cyclophosphamide, DexamethasoneThalidomide + Cyclophosphamide + Dexamethasone |
| Group B induction therapy | Active comparator | Drug: Thalidomide, Dexamethasonethalidomide + dexamethasone |
| Group C induction therapy | Active comparator | Drug: Thalidomide, Melphalan, Prednisonethalidomide + melphalan + prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- > 65 years old and non candidate for autologous stem cell transplant
- Patient must be newly diagnosed with Multiple Myeloma according to establish criteria symptoms. Steroid pulses administration are allowed for any required emergency prior to starting induction therapy or bisphosphonates administration
- Patient must have measurable disease, defined as follows: for secretory multiple myeloma, measurable disease is defined by the presence of measurable monoclonal component in serum or in urine excretion if light chain is greater than or equal to 200 mg/24 hours(Annex 5)
- Measured ECOG < 2 state level.
- The patient must have a life expectancy greater than 3 months.
Key exclusion criteria (8 listed)
- Non-secretory MM.
- Previous treatment for multiple myeloma with the exception of steroid pulses for any emergency that requires treatment before beginning the induction, administration of bisphosphonates or radiation therapy.
- Basal peripheral neuropathy higher than grade 2 within 14 days of inclusion.
- Known thalidomide hypersensitivity.
- Use of any investigational agent within 30 days prior to their inclusion.
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, Cyclophosphamide, DexamethasoneThalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Cyclophosphamide - 50mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally(two pulses the first two cycles in days 1-4 and 15-18 and then a single pulse in each other cycle) during 9 cycles of 28 days. | Drug | Group A induction therapy |
| Thalidomide, DexamethasoneThalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally, in three pulses (days 1 to 4, 9 to 12 and 17 20) odd cycles and a single pulse treatment in pairs cycles, during 9 cycles of 28 days each cycle | Drug | Group B induction therapy |
| Thalidomide, Melphalan, Prednisonethalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle; melphalan - 4 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle; prednisone - 40 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle | Drug | Group C induction therapy |
Primary outcome
Response rate
Time frame: 36 months
Response rate is evaluated between the 3 treatment arms
Duration of response
Time frame: 36 months
Duration of response was defined as the time to the first evidence of laboratorisl progreesion.
3 secondary outcomes
overall survival
Time frame: 36 months
event-free survival
Time frame: 36 months
progression free-survival
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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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.
Vania Hungria, PhD MD principal investigator
Santa Casa de Misericordia de São Paulo
3 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, Cyclophosphamide, Dexamethasone, Thalidomide, Dexamethasone and Thalidomide, Melphalan, Prednisone in people with Multiple Myeloma, run by Grupo de Estudos Multicentricos em Onco-Hematologia at 3 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 13 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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 (time frame: 36 months). The study lists 2 primary outcomes in all. 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 2012.