Back to resultsIberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Thalidomide, Cyclophosphamide, Dexamethasone
Thalidomide, Dexamethasone
Thalidomide, Melphalan, Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, thalidomide, comparative, elderly
Eligibility Criteria
Inclusion Criteria:
- > 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:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Universidade Federal do Rio Grande do Sul
- Hospital Universitário Clementino Fraga Filho
- Santa Casa de Misericórdia de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A induction therapy
Group B induction therapy
Group C induction therapy
Arm Description
Thalidomide + Cyclophosphamide + Dexamethasone
thalidomide + dexamethasone
thalidomide + melphalan + prednisone
Outcomes
Primary Outcome Measures
Response rate
Response rate is evaluated between the 3 treatment arms
Duration of response
Duration of response was defined as the time to the first evidence of laboratorisl progreesion.
Secondary Outcome Measures
overall survival
Overall survival (OS) was defined as the interval from randomization to death or the last follow-up for surviving patients.
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)
progression free-survival
Progression free-survival was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
Full Information
NCT ID
NCT01532856
First Posted
February 10, 2012
Last Updated
February 14, 2012
Sponsor
Grupo de Estudos Multicentricos em Onco-Hematologia
1. Study Identification
Unique Protocol Identification Number
NCT01532856
Brief Title
Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo de Estudos Multicentricos em Onco-Hematologia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, thalidomide, comparative, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A induction therapy
Arm Type
Active Comparator
Arm Description
Thalidomide + Cyclophosphamide + Dexamethasone
Arm Title
Group B induction therapy
Arm Type
Active Comparator
Arm Description
thalidomide + dexamethasone
Arm Title
Group C induction therapy
Arm Type
Active Comparator
Arm Description
thalidomide + melphalan + prednisone
Intervention Type
Drug
Intervention Name(s)
Thalidomide, Cyclophosphamide, Dexamethasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Thalidomide, Dexamethasone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Thalidomide, Melphalan, Prednisone
Intervention Description
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
Primary Outcome Measure Information:
Title
Response rate
Description
Response rate is evaluated between the 3 treatment arms
Time Frame
36 months
Title
Duration of response
Description
Duration of response was defined as the time to the first evidence of laboratorisl progreesion.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
overall survival
Description
Overall survival (OS) was defined as the interval from randomization to death or the last follow-up for surviving patients.
Time Frame
36 months
Title
event-free survival
Description
Event-free survival was defined as the interval from randomization to any event (death or descontinuation due to protocol violation or non-acceptable toxicities)
Time Frame
36 months
Title
progression free-survival
Description
Progression free-survival was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 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:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vania Hungria, PhD MD
Organizational Affiliation
Santa Casa de Misericordia de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
Country
Brazil
Facility Name
Santa Casa de Misericórdia de São Paulo
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
We'll reach out to this number within 24 hrs