NCT00253578

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

November 11, 2005

Last Update Submit

January 4, 2013

Conditions

Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

  • Overall response rate (confirmed CR, R and PR)

    Up to 3 years

  • Incidence of qualitative and quantitative toxicities associated with this regimen

    Up to 3 years

  • Overall survival

    Up to 3 years

  • Progression-free survival

    From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

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

Drug: sorafenib tosylateOther: laboratory biomarker analysis

Interventions

sorafenib tosylateDRUG

Given PO

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment (sorafenib tosylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (sorafenib tosylate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mohamad Hussein

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

March 1, 2006

Primary Completion

November 1, 2007

Last Updated

January 7, 2013

Record last verified: 2013-01

Locations

US(1)