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

NCT00483262 | Completed Phase 1 Results DMC

• 1 other identifier: 06-365
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma

Keywords

Temsirolimus; Bortezomib

Outcome Measures

Primary Outcomes (2)

• Toxicity. Number of Patients With Specific Toxicities Are Reported.

  Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.

  10 months

• Best Response to Combination Treatment

  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 Outcomes (1)

• Progression-Free Survival

  10 months

Study Arms (1)

CCI779 and Bortezomib Phase I/II

EXPERIMENTAL

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; Drug: Bortezomib

Interventions

CCI-779 DRUG

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

Also known as: Temsirolimus

CCI779 and Bortezomib Phase I/II

Bortezomib DRUG

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

Also known as: Velcade

CCI779 and Bortezomib Phase I/II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 21345726 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

temsirolimus; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Irene Ghobrial, MD
• Organization: Dana-Farber Cancer Institute

irene_ghobrial@dfci.harvard.edu

617-632-4198

Study Officials

• Irene Ghobrial, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 6, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2012
• Last Updated: November 11, 2013
• Results First Posted: May 10, 2013

Record last verified: 2013-10

Locations

US (3)