Lenalidomide, Dexamethasone and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant For Multiple Myeloma
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Purpose
This clinical trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma. 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
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma |
Drug: lenalidomide Drug: dexamethasone Drug: clarithromycin |
Phase 2 |
| 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 |
- Incidence of grade IV non-hematological toxicities (except deep venous thrombosis [DVT] and pulmonary emboli) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Time to disease progression [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (clarithromycin, dexamethasone, lenalidomide)
Patients receive clarithromycin PO BID and dexamethasone PO 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 lenalidomide PO QD 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 PO
Other Names:
Drug: dexamethasone
Given PO
Other Names:
Drug: clarithromycin
Given PO
Other Names:
|
Detailed Description:
PRIMARY 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 clarithromycin orally (PO) twice daily (BID) and dexamethasone PO 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 lenalidomide PO once daily (QD) 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 |
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 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 Food and Drug Administration (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 human immunodeficiency virus (HIV) positivity with pre-transplant evaluation
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: | Leona Holmberg | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00445692 History of Changes |
| Other Study ID Numbers: | 2135.00, NCI-2010-02116 |
| Study First Received: | March 7, 2007 |
| Last Updated: | February 5, 2013 |
| 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 May 16, 2013