Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
Information source: Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Thalidomide, Cyclophosphamide, Dexamethasone (Drug); Thalidomide, Dexamethasone (Drug); Thalidomide, Melphalan, Prednisone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Grupo de Estudos Multicentricos em Onco-Hematologia Official(s) and/or principal investigator(s): Vania Hungria, PhD MD, Principal Investigator, Affiliation: Santa Casa de Misericordia de São Paulo
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rateDuration of response
Secondary outcome: overall survivalevent-free survival progression free-survival
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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:
1. 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.
2. Corrected serum calcium ≤ 14mg/dl.
3. Aspartate transaminase (AST): ≤ 2. 5 x normal upper limit.
4. Alanine transaminase (ALT):): ≤ 2. 5 x normal upper limit.
5. Total bilirubin: ≤ 1. 5 x normal upper limit.
6. 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.
Locations and Contacts
Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, Brazil
Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil
Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil
Additional Information
Starting date: January 2007
Last updated: February 14, 2012
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