Clinical Trial: Sorafenib in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) November 2005

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI) Identifier: NCT00253578


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
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Refractory Plasma Cell Neoplasm
 Drug: sorafenib
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Sorafenib in Patients With Relapsed or Refractory Multiple Myeloma

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


  • 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.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both


  • 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 20% by bone marrow aspirate
  • Monoclonal serum free light chains > 5 times normal plus abnormal kappa:lambda ratio by Freelite test
  • 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


Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


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


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


  • Creatinine normal


  • 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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to take oral medications without crushing, dissolving, or chewing tablets
  • No significant neurotoxicitygrade 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


Biologic therapy

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


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


  • At least 2 weeks since prior external-beam radiotherapy


  • 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

Location and Contact Information

Please refer to this study by identifier  NCT00253578

Study chairs or principal investigators

Mohamad A. Hussein, MD,  Principal Investigator,  The Cleveland Clinic   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000449973; SWOG-S0434
Last Updated:  December 8, 2005
Record first received:  November 11, 2005 Identifier:  NCT00253578
Health Authority: United States: Federal Government processed this record on 2006-01-10


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