Overview

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