Temsirolimus and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with dexamethasone may kill more cancer cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Everolimus; Sirolimus

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