A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis
dexamethasone
+ lenalidomide
Amylose par chaîne légère d'immunoglobuline+17
+ Amyloïdose
+ Troubles des Protéines Sanguines
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis. * Determine the objective hematologic response rate in patients treated with this drug. * Determine amyloid organ disease response in patients treated with this drug. Secondary * Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone. * Determine the toxicity of CC-5013 in combination with dexamethasone in these patients. OUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study. Patients are followed annually. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.82 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed primary systemic (AL) amyloidosis * Tissue amyloid deposits or positive fat aspirate * Meets 1 of the following criteria for AL type disease: * Serum or urine monoclonal protein by immunofixation electrophoresis * Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-2 Life expectancy * Not specified Hematopoietic * White blood count\> 3,000/mm\^3 * Hemoglobin \> 8 g/dL * Platelet count \> 100,000/mm\^3 * Absolute neutrophil count \> 1,000/mm\^3 Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN PRIOR CONCURRENT THERAPY: Biologic therapy * Prior thalidomide for AL amyloidosis allowed Chemotherapy * More than 4 weeks since prior cytotoxic chemotherapy Endocrine therapy * Prior steroids for AL amyloidosis allowed Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Prior surgery allowed Other * Recovered from all prior therapy Exclusion Criteria: * No secondary or familial amyloidosis * No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions * No prior CC-5013 Renal * No dialysis Cardiovascular * No symptomatic cardiac arrhythmia * No oxygen-dependent restrictive cardiomyopathy Other * No untreated or uncontrolled infection * No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast * No other serious medical illness that would preclude study participation * No history of hypersensitivity reaction to thalidomide * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Cancer Research Center at Boston Medical Center
Boston, United StatesOuvrir Cancer Research Center at Boston Medical Center dans Google Maps