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.
- > 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
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.
- 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.