NCT00079456

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

March 8, 2004

Last Update Submit

October 10, 2013

Conditions

Refractory Multiple MyelomaStage I Multiple MyelomaStage II Multiple MyelomaStage III Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with objective overall response rate (PR+CR)

    Up to 5 years

Secondary Outcomes (2)

  • Progression-free survival

    Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years

  • Incidence of toxicities

    Up to 5 years

Study Arms (1)

Treatment (temsirolimus)

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.

Drug: temsirolimusOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

temsirolimusDRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel
Treatment (temsirolimus)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (temsirolimus)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (temsirolimus)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

temsirolimusSirolimus

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Michael Grever

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2004

First Posted

March 10, 2004

Study Start

February 1, 2004

Primary Completion

February 1, 2007

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

US(2)