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Sorafenib in Treating Patients With Relapsed or Refractory Multiple Myeloma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00253578
  Purpose

RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with relapsed or refractory multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: sorafenib tosylate
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients With Relapsing or Resistant Multiple Myeloma

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

Primary Outcome Measures:
  • Overall response rate (confirmed complete response, response, and partial response) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Overall and progression-free survival [ Designated as safety issue: No ]
  • Correlation of gene expression signatures with response [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2006
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the overall response rate (confirmed complete response, response, and partial response) in patients with relapsed or refractory multiple myeloma treated with sorafenib.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the overall and progression-free survival of patients treated with this drug.
  • Correlate gene expression signatures with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of active multiple myeloma

    • Previously treated disease
  • Measurable disease, as defined by ≥ 1 of the following criteria:

    • Serum M-protein level ≥ 1 gm/dL by serum protein electrophoresis
    • Urinary M-protein excretion ≥ 0.2 g/24 hours by urine electrophoresis
    • Bone marrow plasmacytosis ≥ 30% by bone marrow aspirate or biopsy
    • Involved free light chain level ≥ 10 mg/dL
  • Relapsed or refractory disease, as defined by 1 of the following criteria:

    • Relapsed disease after prior autologous stem cell transplantation
    • Relapsed or refractory disease after ≥ 1 prior therapy for myeloma
  • No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome

PATIENT CHARACTERISTICS:

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 750/mm^3
  • Platelet count > 75,000/mm^3
  • No evidence of bleeding diathesis

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 5 times ULN

Renal

  • Creatinine normal

Cardiovascular

  • No significant history of cardiac disease
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina pectoris
  • No cardiac ventricular arrhythmia requiring medication
  • No uncontrolled hypertension

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Must be able to take oral medications without crushing, dissolving, or chewing tablets
  • No significant neurotoxicity ≥ grade 2
  • No active infection requiring antibiotics
  • No uncontrolled diabetes
  • No serious medical or psychiatric illness that would preclude study participation
  • No other prior malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 6 weeks since prior autologous stem cell transplantation

Chemotherapy

  • At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
  • At least 2 weeks since prior nonmyelosuppressive chemotherapy

Radiotherapy

  • At least 2 weeks since prior external-beam radiotherapy

Other

  • Recovered from all prior treatment
  • No prior sorafenib
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
  • No concurrent rifampin or Hypericum perforatum (St. John's wort)
  • No concurrent therapeutic anticoagulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253578

  Show 148 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Mohamad A. Hussein, MD The Cleveland Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000449973, SWOG-S0434
Study First Received: November 11, 2005
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00253578  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Sorafenib
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009