Completed

Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

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What is being tested

temsirolimus

+ pharmacological study
+ laboratory biomarker analysis
Drug
Other
Who is being recruted

Refractory Multiple Myeloma
+1

+ Stage I Multiple Myeloma
+ Stage II Multiple Myeloma
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2004

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: October 11, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

This phase II trial is studying how well temsirolimus works in treating patients with relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work in different ways to stop cancer cells from dividing so they stop growing or die. PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779. SECONDARY OBJECTIVES: I. Determine the progression-free survival of patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Determine the presence of PTEN mutation in patients treated with this drug. IV. Correlate the pharmacokinetics of this drug with response in these patients. V. Correlate the pharmacodynamic effects of this drug with response in these patients. OUTLINE: This is an open-label study. Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Official TitleA Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma 
Principal SponsorNational Cancer Institute (NCI)
Last updated: October 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Criteria

Inclusion Criteria: * Diagnosis of multiple myeloma (MM) * Salmon-Durie stage IIA or IIIA OR progressive stage IA disease * Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria * The following are considered major criteria: * Plasmacytoma on tissue biopsy * Bone marrow plasmacytosis with \>= 30% plasma cells * Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5 g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the presence of Bence-Jones protein of \>= 1 g/24 hour-urine collection * The following are considered minor criteria: * Bone marrow plasmacytosis 10-29% * Monoclonal globulin spike present, but less than the levels defined for a major criterion * Lytic bone lesion * Decrease in normal IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL * No non-secretory MM (absent serum or urinary M-protein) * Failed at least 1 prior systemic therapy\* (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib) for the treatment of MM * No solitary plasmacytoma * Performance status - ECOG 0-2 * More than 6 months * Absolute neutrophil count \> 1,200/mm\^3 * Platelet count \> 75,000/mm\^3 * AST and ALT =\< 2.5 times upper limit of normal (ULN) * Bilirubin =\< 1.5 times ULN * Creatinine =\< 1.5 times ULN * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Fasting cholesterol =\< 350 mg/dL * Triglycerides =\< 400 mg/dL * No other concurrent uncontrolled illness * No active or ongoing infection requiring oral or IV antibiotics * No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779 * No other prior or concurrent malignancy or myelodysplasia except for the following: * Basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix * Localized cancer treated with surgery only with no evidence of disease for \> 5 years * No psychiatric illness or social situation that would preclude study compliance * More than 4 weeks since prior thalidomide and recovered * Prior high-dose chemotherapy and stem cell transplantation allowed * More than 4 weeks since prior chemotherapy and recovered * More than 4 weeks since prior high-dose corticosteroids and recovered * More than 4 weeks since prior bortezomib and recovered * More than 4 weeks since other prior anti-myeloma systemic therapy and recovered * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, United StatesSee the location
Suspended
Ohio State University Medical CenterColumbus, United States

Completed2 Study Centers