Sorafenib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 2

Conditions studied: Refractory Multiple Myeloma

In brief

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

Key facts

Study ID: NCT00253578
Run by: National Cancer Institute (NCI)
People needed: 40
Starts: 2006-03-01
Last updated by the study team: 2013-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with measurable disease present to evaluate response; all tests for establishing baseline disease status (serum protein electrophoresis, urine protein electrophoresis and bone marrow biopsy) must be performed within 28 days prior to registration and MUST be documented on the Baseline and Follow-up Tumor Assessment Form for Multiple Myeloma
Patients must have relapsed or resistant disease, defined as relapsing after autologous stem cell transplantation or is either relapsing or is resistant after >= 1 line of prior therapy for myeloma; a minimum of 42 days must have elapsed since prior transplant
Relapse: is defined as the occurrence of any of the following during or after previous treatment:
A myeloma protein increase by more than 100% from the lowest previously recorded level
A myeloma protein increase above the response criteria for PR
Reappearance of any myeloma peak that had disappeared during the previous treatment
Increase in the size and number of lytic bone lesions and/or focal lesions recognized in radiographic studies (x-ray, MRI, PET and/or CT scans)
Resistant disease: is defined as disease not responding (i.e. not achieving CR, R, PR) to previous therapy
Patients must be off myelosuppressive chemotherapy for >= 21 days (>= 6 weeks for nitrosoureas) and non-myelosuppressive chemotherapy and XRT for >= 14 days and recovered from all treatment associated toxicities prior to registration
Patients must have a Zubrod Performance Status (PS) of 0-2
Patients must have received no prior treatment with BAY 43-9006
Patients must have currently have no significant neurotoxicity, defined as Grade >= 2 neurotoxicity per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Patients must have no evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) Syndrome
There must be no active infection requiring antibiotics
Bilirubin =< 1.5 times the institutional upper limit of normal (IULN)
AST (SGOT or SGPT) =< 5 times the institutional upper limit of normal (IULN)
Serum creatinine =< the institutional upper limit of normal (IULN)
ANC > 750/ul
Platelet count > 75,000/ul
Patients must be able to take oral medication without crushing, dissolving or chewing tablets
Patients must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, and phenobarbital), rifampin, or St. John's Wort
Patients must not have a significant history of cardiac disease, e.g., uncontrolled hypertension, unstable angina, congestive-heart failure, and myocardial infarction within the last six months, or cardiac ventricular arrhythmias requiring medication
Patients must not have any evidence of bleeding diathesis, uncontrolled diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Patients must not be on therapeutic anticoagulation
No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years

Where it is running

Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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