Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00079456
First received: March 8, 2004
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Drug: temsirolimus
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients with objective overall response rate (PR+CR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Incidence of toxicities [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: February 2004
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (temsirolimus)
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: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779.

SECONDARY OBJECTIVES:

I. Determine the progression-free survival of patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Determine the presence of PTEN mutation in patients treated with this drug.

IV. Correlate the pharmacokinetics of this drug with response in these patients.

V. Correlate the pharmacodynamic effects of this drug with response in these patients.

OUTLINE: This is an open-label study.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Performance status - ECOG 0-2
  • More than 6 months
  • Absolute neutrophil count > 1,200/mm^3
  • Platelet count > 75,000/mm^3
  • AST and ALT =< 2.5 times upper limit of normal (ULN)
  • Bilirubin =< 1.5 times ULN
  • Creatinine =< 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Fasting cholesterol =< 350 mg/dL
  • Triglycerides =< 400 mg/dL
  • No other concurrent uncontrolled illness
  • No active or ongoing infection requiring oral or IV antibiotics
  • No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779
  • No other prior or concurrent malignancy or myelodysplasia except for the following:

    • Basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Localized cancer treated with surgery only with no evidence of disease for > 5 years
  • No psychiatric illness or social situation that would preclude study compliance
  • More than 4 weeks since prior thalidomide and recovered
  • Prior high-dose chemotherapy and stem cell transplantation allowed
  • More than 4 weeks since prior chemotherapy and recovered
  • More than 4 weeks since prior high-dose corticosteroids and recovered
  • More than 4 weeks since prior bortezomib and recovered
  • More than 4 weeks since other prior anti-myeloma systemic therapy and recovered
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079456

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Grever Ohio State University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00079456     History of Changes
Other Study ID Numbers: NCI-2012-01448, NCI-2012-01448, NCI-6186, OSU-0347, CDR0000355767, OSU-2003C0090, 0347, 6186, R21CA112894, N01CM62207
Study First Received: March 8, 2004
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014