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

NCT00483262

Last updated date
Study Location
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma
Official Title  ICMJE Phase I/II Trial of Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: CCI-779
    Given by injection once a week for 5 weeks (5 weeks equals one cycle) for up to 8 cycles
    Other Name: Temsirolimus
  • Drug: Bortezomib
    Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles
    Other Name: Velcade
Study Arms  ICMJE 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.
Interventions:
  • Drug: CCI-779
  • Drug: Bortezomib
Publications * Ghobrial IM, Weller E, Vij R, Munshi NC, Banwait R, Bagshaw M, Schlossman R, Leduc R, Chuma S, Kunsman J, Laubach J, Jakubowiak AJ, Maiso P, Roccaro A, Armand P, Dollard A, Warren D, Harris B, Poon T, Sam A, Rodig S, Anderson KC, Richardson PG. Weekly bortezomib in combination with temsirolimus in relapsed or relapsed and refractory multiple myeloma: a multicentre, phase 1/2, open-label, dose-escalation study. Lancet Oncol. 2011 Mar;12(3):263-72. doi: 10.1016/S1470-2045(11)70028-6. Epub 2011 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2013)
63
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2007)
31
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483262
Other Study ID Numbers  ICMJE 06-365
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Irene Ghobrial, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator:Irene Ghobrial, MDDana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP