Status:
COMPLETED
Temsirolimus and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of temsirolimus when given together with dexamethasone in treating patients with recurrent or refractory multiple myeloma. Temsirolimus ma...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the toxicity and safety of temsirolimus in combination with dexamethasone in patients with recurrent or refractory multiple myeloma. II. To assess a dose of temsirol...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00693433
Start Date
December 1 2008
Last Update
December 4 2015
Active Locations (1)
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1
Veteran's Administration Medical Center
Las Angeles, California, United States, 90073