Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01532856
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:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01532856
Study Brief:
Protocol Section:
NCT01532856