Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone a Previous Autologous or Syngeneic Bone Marrow or Stem Cell Transplant for Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00182663

Purpose

RATIONALE: Biological therapies, such as thalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Thalidomide and clarithromycin may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work 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 an autologous or syngeneic bone marrow or stem cell transplant may be an effective treatment for multiple myeloma.

PURPOSE: This phase II trial is studying how well giving thalidomide together with dexamethasone and clarithromycin works in treating patients who have undergone a previous autologous or syngeneic bone marrow or stem cell transplant for multiple myeloma.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: clarithromycin Drug: dexamethasone Drug: thalidomide Procedure: adjuvant therapy	Phase II

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

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Median time to disease progression [ Designated as safety issue: No ]
Survival [ 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)

Detailed Description:

OBJECTIVES:

Determine the toxicity of maintenance therapy comprising thalidomide, dexamethasone, and clarithromycin in patients with multiple myeloma who have undergone prior autologous or syngeneic bone marrow or peripheral blood stem cell transplantation.
Determine the median time to disease progression in patients treated with this regimen.
Determine overall survival and disease-free survival of patients treated with this regimen.

OUTLINE: Patients receive oral thalidomide once daily, oral dexamethasone once weekly, and oral clarithromycin twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of 1 year of treatment, patients discontinue oral clarithromycin, receive tapering doses of oral dexamethasone once weekly for 8 weeks, and continue to receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 years.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma
- Any stage disease
Has undergone prior high-dose (i.e., ≥ 140 mg/m^2) melphalan therapy and autologous or syngeneic bone marrow or peripheral blood stem cell transplantation within the past 30-120 days

PATIENT CHARACTERISTICS:

Age

Not specified

Performance status

Karnofsky 70-100%

Life expectancy

Not specified

Hematopoietic

Platelet count > 50,000/mm^3 (transfusion independent)
Absolute granulocyte count > 1,500/mm^3 (for 5 calendar days after recovery from high-dose melphalan therapy)

Hepatic

SGOT or SGPT ≤ 2.5 times upper limit of normal
Bilirubin ≤ 2 mg/mL (unless due to Gilbert's disease)

Renal

Not specified

Cardiovascular

No history of myocardial infarction
No history of deep vein thrombosis
No history of arterial occlusions
LVEF ≥ 45%
No congestive heart disease
No coronary artery disease

Pulmonary

No history of pulmonary emboli

Other

Not pregnant or nursing
Negative pregnancy test
Fertile female patients must use effective contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after the completion of study treatment (during and for 4 weeks after the completion of study treatment for male patients)
No blood, ova, or sperm donation during study treatment
No history of seizures
No allergy to any study drugs
No untreated systemic infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
Recovered from prior autologous or syngeneic bone marrow or peripheral blood stem cell transplantation
Combination therapy with thalidomide, clarithromycin, and steroids prior to transplantation allowed provided disease responded to the combination therapy

Chemotherapy

See Disease Characteristics

Endocrine therapy

See Biologic therapy

Radiotherapy

Not specified

Surgery

Not specified

Other

No prior or concurrent participation on another transplant clinical trial that has evaluated (or is evaluating) disease-free survival or overall survival
No other concurrent anticancer therapy

Contacts and Locations

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

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Leona A. Holmberg, MD, PhD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Holmberg LA, Brandvold A, Bensinger W I: Maintenance therapy with low dose thalidomide, dexamethasone and clarithromycin (biaxin) (BLT-D) following autologous transplant (ASCT) for multiple myeloma (MM). [Abstract] Blood 108 (11): A-5442, 2006.

Responsible Party:	Fred Hutchinson Cancer Research Center ( Leona A. Holmberg )
Study ID Numbers:	CDR0000439530, FHCRC-1767.00, CELGENE-FHCRC-1767.00
Study First Received:	September 15, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00182663 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:

Dexamethasone
Anti-Inflammatory Agents
Immunologic Factors
Thalidomide
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Clarithromycin
Hemorrhagic Disorders

Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Adjuvants, Immunologic
Angiogenesis Inhibitors
Glucocorticoids
Immunosuppressive Agents
Multiple Myeloma
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Thalidomide
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents

Clarithromycin
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Gastrointestinal Agents
Vascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009