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

Completed · Phase 1

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00693433

Run by

National Cancer Institute (NCI)

People needed

15

Starts

2008-12-01

Last updated by the study team

2015-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Veteran's Administration Medical Center — Las Angeles, California, United States

Full record on ClinicalTrials.gov

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