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

October 16, 2013 updated by: Irene Ghobrial, MD, Dana-Farber Cancer Institute

Phase I/II Trial of Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Since we are looking for the highest dose of CCI-779 (Temsirolimus) given in combination with bortezomib (Velcade) that can be given to people without causing the most serious or unmanageable side effects, not everyone who participates in this study will be receiving the same amount of either drug.
  • During the study treatment, participants will be given some medications to decrease the chance they they will have an allergic reaction to CCI-779 (Temsirolimus). After these drugs are given, participants will be receive bortezomib (Velcade) by injection followed by an injection of CCI-779 (Temsirolimus). These drugs wil be given once a week for four weeks (on Days 1, 8, 15, and 22). On the fifth week (Day 29), participants will be given only CCI-779 along with the drugs to decrease the chance of an allergic reaction.
  • The cycle will last 35 days and will occur twice before the doctor evaluates for response. The cycles will be repeated for up to 8 cycles as long as the participant does not have any severe or unmanageable side effects and the disease is responding to treatment.
  • While receiving study treatment, participants will be seen at the clinic at the start of each cycle for the following: complete physical examination, blood work, urine collection, x-ray of bones (if study doctor deems necessary) and an electrocardiogram (prior to treatment and at the end of treatment)
  • A bone skeletal survey will be performed at the end of treatment to measure the size of the participants tumors.
  • After 8 cycles of treatment or if the participant has ended treatment, more tests will be performed. A physical exam, blood work, urine collection, skeletal survey, electrocardiogram, bone marrow biopsy and aspirate will be performed.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University in Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Must have received prior therapy for their myeloma and have relapsed and/or relapsed/refractory multiple myeloma
  • Monoclonal protein in the serum of greater than or equal to 1 gm/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200mg/24 hours, or measurable light chains by free light chain assay of greater than or equal to 10mg/dl, or measurable plasmacytoma
  • ECOG Performance Status 0, 1 or 2
  • Laboratory values as outlined in the protocol

Exclusion Criteria:

  • Uncontrolled infection
  • Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma.
  • Pregnant or nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational within 14 days before enrollment
  • Known to be HIV positive
  • Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Hypersensitivity to bortezomib, boron or mannitol
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical trial
  • Patients who may need or are receiving live vaccines for immunization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCI779 and Bortezomib Phase I/II
In Phase I part, 15 or 25 mg temsirolimus (CCI-779)and 1·3 or 1·6 mg/m² bortezomib was given once a week.In Phase II, patients received intravenous temsirolimus once a week on days 1, 8, 15, 22, and 29 for a cycle of 35 days, and intravenous bortezomib once a week on days 1, 8, 15, and 22 for a cycle of 35 days, the MTD ascertained in the Phase I part.
Drug: CCI-779
Given by injection once a week for 5 weeks (5 weeks equals one cycle) for up to 8 cycles
Other Names:
  • Temsirolimus
Drug: Bortezomib
Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles
Other Names:
  • Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity. Number of Patients With Specific Toxicities Are Reported.
Time Frame: 10 months
Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.
10 months
Best Response to Combination Treatment
Time Frame: 10 months
Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: 10 months
Median time to progression or death
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Millennium Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Irene Ghobrial, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 5, 2007

First Submitted That Met QC Criteria

June 5, 2007

First Posted (Estimate)

June 6, 2007

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

October 16, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on CCI-779

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe