Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
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.
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.