Know Cancer

forgot password

A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients With Relapsing or Resistant Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Refractory Multiple Myeloma

Thank you

Trial Information

A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients With Relapsing or Resistant Multiple Myeloma


I. To assess the overall response rate (confirmed CR, R and PR) in patients with
relapsed/refractory multiple myeloma treated with BAY 43-9006.

II. To evaluate qualitative and quantitative toxicities associated with this regimen.

III. To assess overall and progression-free survival in this group of patients treated with
this regimen.

IV. To explore, in a preliminary manner, associations between gene expression signatures and

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.

Inclusion Criteria:

- 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

- 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

- 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

- 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

- Pregnant or nursing women may not participate in this trial because of increased risk
of fetal harm including fetal death from the chemotherapeutic agents; women/men of
reproductive potential may not participate unless they have agreed to use an
effective contraceptive method

- Institutions must have IRB approval of S0309 ("Myeloma Specimen Repository Protocol,
Ancillary"); patients must be offered participation in S0309; with the patient's
consent, bone marrow aspirates and serum specimens will be submitted for testing via
S0309; patients must be registered separately to S0309 in order for institutions to
receive credit for specimen submission to S0309; NOTE: immediately following S0434
registration, the CRA will need to have completed the S0309 Registration Form and
eligibility worksheet in hand for use

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal

- At the time of patient registration, the treating institution's name and ID number
must be provided to the Data Operations Center in Seattle in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered into the data base

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (confirmed CR, R and PR)

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Mohamad Hussein

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Southwest Oncology GroupSan Antonio, Texas  78245