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:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT00693433
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed multiple myeloma
* Measurable levels of M protein in serum and/or urine
* Recurrent or refractory disease
* Progressive disease after treatment with ≥ 2 separate chemotherapeutic regimens
* At least 1 of the regimens must have included high-dose dexamethasone (40 mg on days 1-4, 9-12, and 17-20) or medium-dose dexamethasone (40 mg on days 1, 8, 15, and 22) of a 28-day course
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm \^3
* Total bilirubin \< 2 mg/dL
* AST and ALT \< 3 times upper limit of normal
* Creatinine \< 2 mg/dL
* Fasting cholesterol \< 350 mg/dL
* Fasting triglycerides \< 400 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to temsirolimus or dexamethasone
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Poorly controlled hypertension
* Diabetes mellitus
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would limit compliance with study requirements
* See Disease Characteristics
* At least 4 weeks since prior cytotoxic therapy
* More than 4 weeks since prior chemotherapy and recovered
* No concurrent anticonvulsive or antiarrhythmic medications
* No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) or other CYP3A4 inhibitors or inducers (e.g., rifampin or Hypericum perforatum \[St. John wort\])
* No concurrent prophylactic hematopoietic colony-stimulating factors
* No other concurrent investigational therapy
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00693433
Study Brief:
Protocol Section:
NCT00693433