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Myeloma |
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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
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 |
|---|---|---|
| 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
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
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 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
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
- Negative pregnancy test
- 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
Location and Contact Information
Mohamad A. Hussein, MD, Principal Investigator, The Cleveland Clinic
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: December 8, 2005
Record first received: November 11, 2005
ClinicalTrials.gov Identifier: NCT00253578
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Myeloma (National Women's Health Information Center)
- Understanding Drug Therapy and Managing Side Effects (The Leukemia and Lymphoma Society)

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