Lenalidomide, Dexamethasone and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant For Multiple Myeloma - 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:	NCT00445692

Purpose

RATIONALE: Biological therapies, such as lenalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. 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 lenalidomide together with dexamethasone and clarithromycin may be an effective treatment for multiple myeloma.

PURPOSE: This clinical trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma

Condition	Intervention
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma	Drug: lenalidomide Drug: dexamethasone Drug: clarithromycin

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 Lenalidomide, 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 Dexamethasone acetate Doxiproct plus Clarithromycin Lenalidomide CC 5013 Dexamethasone Sodium Phosphate

U.S. FDA Resources

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

Primary Outcome Measures:

Toxicity of this proposed treatment with clarithromycin (Biaxin), dexamethasone, and lenalidomide [ Time Frame: The first 3 months of therapy ] [ Designated as safety issue: Yes ]
Time to disease progression [ Time Frame: Every 2 weeks for the first 3 months and then monthly or every 3 months during treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	January 2007
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive oral clarithromycin twice daily and oral dexamethasone once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year* in the absence of disease progression or unacceptable toxicity. Patients also receive oral lenalidomide once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.	Drug: lenalidomide Given orally Other Names: CC-5013 IMiD-1 Revlimid Drug: dexamethasone Given orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: clarithromycin Given orally Other Names: Abbott-56268 Biaxin CLARITH

Arms

Assigned Interventions

Experimental: Arm I

Patients receive oral clarithromycin twice daily and oral dexamethasone once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year* in the absence of disease progression or unacceptable toxicity. Patients also receive oral lenalidomide once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Drug: lenalidomide

Given orally

Other Names:

CC-5013
IMiD-1
Revlimid

Drug: dexamethasone

Given orally

Other Names:

Aeroseb-Dex
Decaderm
Decadron
DM
DXM

Drug: clarithromycin

Given orally

Other Names:

Abbott-56268
Biaxin
CLARITH

Detailed Description:

OBJECTIVES:

I. Evaluate the toxicity of the use of Lenalidomide/Biaxin/Dexamethasone as maintenance therapy after autologous/syngeneic transplant.

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

OUTLINE: Patients receive oral clarithromycin twice daily and oral dexamethasone once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year* in the absence of disease progression or unacceptable toxicity. Patients also receive oral lenalidomide once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

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

Eligibility

Ages Eligible for Study:	18 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/PBSC or BM rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial which is also evaluating long-term disease free survival or survival
Platelet count (transfusion independent) > 50,000 cells/mm^3 and absolute granulocyte count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose therapy
Patients should be between 30 days to 120 days after transplant
Willingness and ability to comply with FDA-mandated REV ASSIST Program, Celgene System for Lenalidomide Education and Prescribing Safety
Signing a written informed consent form

Exclusion Criteria:

Karnofsky score less than 70
A left ventricular ejection fraction less than 45% immediately pre transplant; patients with congestive heart disease with transplant, history of MI, or history of coronary artery disease
Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease), SGOT or SGPT > 2.5 x upper limit of normal
Calculated by Cockcroft-Gault formula or measured serum creatinine clearance < 25 ml/minute
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 Lenalidomide/Biaxin and Steroid without response
Patients allergic to Lenalidomide, Biaxin or Dexamethasone
Referring physician not registered with REV ASSIST program or unwilling to oversee the care of the patients on study and comply with the FDA-mandated REV ASSIST Program
Patients unwilling to practice adequate forms of contraception if clinically indicated until 30 days after stopping therapy; 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 30 days after stopping drugs
Patients with >= grade 3 peripheral neuropathy
Prior history of uncontrollable side effects to Dexamethasone therapy
A prior history of HIV positivity with pre-transplant evaluation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445692

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:	NCT00445692 History of Changes
Other Study ID Numbers:	2135.00, NCI-2010-02116
Study First Received:	March 7, 2007
Last Updated:	March 7, 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
Lenalidomide
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

ClinicalTrials.gov processed this record on February 09, 2012