Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma

NCT00483262 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2013-11-11

Study results available
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Summary

The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and bortezomib (Velcade), and the highest dose of this drug that can be given to people safely. We will also be looking at how the combination of the two drugs may work against multiple myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing.

Conditions

Interventions

DRUG

CCI-779

Given by injection once a week for 5 weeks (5 weeks equals one cycle) for up to 8 cycles

DRUG

Bortezomib

Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY
  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY
  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Irene Ghobrial, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-01-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483262 on ClinicalTrials.gov