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Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00182663
Collaborator
National Cancer Institute (NCI) (NIH)
30
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

This phase II trial studies the side effects and how well giving thalidomide, dexamethasone, and clarithromycin together works in treating patients with multiple myeloma previously treated with transplant. Biological therapies, such as thalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone also works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with dexamethasone and clarithromycin after a transplant may be an effective treatment for multiple myeloma

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  1. Evaluate the toxicity of the use of Thalidomide/Biaxin (Clarithromycin)/Dexamethasone as maintenance therapy after autologous/syngeneic transplant.

  2. Evaluate the median time to disease progression. III. Evaluate survival.

OUTLINE:

Patients receive thalidomide orally (PO) once daily (QD), dexamethasone PO once weekly, and clarithromycin PO twice daily (BID). Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (immunomodulator, antiangiogenesis, steroid therapy)

Patients receive thalidomide PO QD dexamethasone PO once weekly, and clarithromycin PO BID. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity.

Drug: clarithromycin
Given PO
Other Names:
  • Abbott-56268
  • Biaxin
  • CLARITH

    • Drug: thalidomide
    Given PO
    Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid

    • Drug: dexamethasone
    Given PO
    Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Toxicity of proposed treatment with clarithromycin, dexamethasone, and thalidomide [First 3 months of therapy]

    Secondary Outcome Measures

    1. Time to disease progression [Up to 15 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Any autologous or syngeneic patient who underwent high dose melphalan (>= 140 mg/m^2) therapy/peripheral blood stem cell (PBSC) or bone marrow (BM) rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial which is also evaluating disease free survival or survival

    • Platelet count (transfusion independent) > 50,000 cells/mm^3 for 5 calendar days after recovery from high dose

    • Absolute granulocyte count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose

    • Patients will start therapy between 30 days to 120 days after transplant

    • Willingness and ability to comply with Food and Drug Administration (FDA)-mandated S.T.E.P.S. (Celgene System for Thalidomide Education and Prescribing Safety) Program

    • Signing a written informed consent form

    Exclusion Criteria:

    • Karnofsky score less than 70

    • A left ventricular ejection fraction less than 45%; patients with congestive heart disease, history of myocardial infarction (MI), or coronary artery disease

    • Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease)

    • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 2.5 x upper limit of normal

    • History of deep venous thrombus, arterial occlusions, or pulmonary emboli

    • Pregnant and/or lactating females

    • Patients who cannot give informed consent

    • Patients with untreated systemic infection

    • Patients with history prior to transplant of treatment with combination therapy Thalidomide/Biaxin and Steroid without response

    • Patients allergic to Thalidomide, Biaxin or Dexamethasone

    • Referring physician not registered with S.T.E.P.S. program or unwilling to oversee the care of the patients on study and comply with the FDA-mandated S.T.E.P.S. Program

    • Patients unwilling to practice adequate forms of contraception if clinically indicated; male patients on study need to be consulted to use latex condoms even if they have had a vasectomy every time they have sex with a woman who is able to have children while they are being treated and for four weeks after stopping drugs

    • Patients with history of seizures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Leona Holmberg, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00182663
    Other Study ID Numbers:
    • 1767.00
    • NCI-2011-00387
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Jun 26, 2017
    Last Verified:
    Apr 1, 2017
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Thalidomide
    Clarithromycin
    Dexamethasone

    Study Results

    No Results Posted as of Jun 26, 2017