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Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma


Phase 2
14 Years
N/A
Open (Enrolling)
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma


OBJECTIVES:

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

II. 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity of proposed treatment with clarithromycin, dexamethasone, and thalidomide

Outcome Time Frame:

First 3 months of therapy

Safety Issue:

Yes

Principal Investigator

Leona Holmberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

1767.00

NCT ID:

NCT00182663

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109