Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant
This study is ongoing, but not recruiting participants.
Sponsor:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00182663
First received: September 15, 2005
Last updated: November 20, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Thalidomide
Dexamethasone acetate
Dexamethasone sodium phosphate
Clarithromycin
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:
Drug: thalidomide
Given PO
Other Names:
Drug: dexamethasone
Given PO
Other Names:
|
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/University of Washington Cancer Consortium
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: | November 20, 2012 |
| 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 June 17, 2013