Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00182663

Purpose

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	Intervention	Phase
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma	Drug: clarithromycin Drug: thalidomide Drug: dexamethasone	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Thalidomide Dexamethasone acetate Doxiproct plus Clarithromycin Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Toxicity of proposed treatment with clarithromycin, dexamethasone, and thalidomide [ Time Frame: First 3 months of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to disease progression [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2003
Estimated Primary Completion Date:	October 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182663

Locations

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

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Leona Holmberg

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

More Information

No publications provided

Responsible Party:	Holmberg, Leona, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier:	NCT00182663 History of Changes
Other Study ID Numbers:	1767.00, NCI-2011-00387
Study First Received:	September 15, 2005
Last Updated:	July 29, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate

Dexamethasone
Dexamethasone 21-phosphate
Thalidomide
BB 1101
Clarithromycin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012