- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00182663
Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant
Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Givet PO
Andre navne:
Givet PO
Andre navne:
Given PO
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Toxicity of proposed treatment with clarithromycin, dexamethasone, and thalidomide
Tidsramme: First 3 months of therapy
|
First 3 months of therapy
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to disease progression
Tidsramme: Up to 15 years
|
Up to 15 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Myelomatose
- Neoplasmer, Plasmacelle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Autonome agenter
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Antibakterielle midler
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- Leprostatiske midler
- Proteinsyntesehæmmere
- Dexamethason
- Thalidomid
- Clarithromycin
Andre undersøgelses-id-numre
- 1767.00
- NCI-2011-00387 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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