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- Essai clinique NCT01731886
Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma
21 janvier 2020 mis à jour par: Suzanne Lentzsch, MD, Columbia University
A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma.
This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000 deaths each year in the United States.
Approximately one third of myeloma patients develop hypercalcemia and about two thirds present with anemia.
As the second most common hematologic malignancy, myeloma remains incurable.
In the last forty years, options for therapy have included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with those regimens continues to be inevitable with a median survival of 3 years.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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New York, New York, États-Unis, 10032
- Columbia University
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated.
- Bone marrow plasmacytosis with > or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma.
- Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or > 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis.
- Age > or = 18 years.
- Life expectancy of greater than 12 months.
- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%).
Adequate organ and marrow function as defined below:
- Hgb > or = 9 g/dL
- Absolute Neutrophil Count > or = 1,500/ ml
- Platelets > or = 50,000/mm3
- Total Bilirubin < or = 1.5 mg/dL
- Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) < or = 2.5 X upper limit of normal (ULN)
- Creatinine < 2.0 mg/dL
- Creatinine Clearance > or = 50 ml/min
- Registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- Ability to understand and the willingness to sign a written informed consent document.
- Subjects with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months.
- Must be willing and able to take prophylaxis with either aspirin at 81 mg/day or alternative prophylaxis with either low molecular weight heparin or warfarin as recommended.
- Eligible for transplant with an age up to and including 75 years.
- Subjects in Arm A who are refusing transplant can go onto Arm B and will be evaluated separately.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per millilitre (mIU/mL) within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence or 2 acceptable methods of birth control. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom.
Exclusion Criteria:
- Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.
- Receiving any other investigational agents or therapy within 28 days of baseline.
- Brain metastases.
- Subjects who are pregnant or breast feeding.
- History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3).
If a subject is on full-dose anticoagulants, the following criteria should be met for enrollment:
- Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
- Must not have thrombocytopenia requiring transfusion.
- Must have a platelet count > 50,000.
- Must have stable INR between 2-3.
- Smoldering myeloma or monoclonal gammopathy of undetermined significance.
- Active, uncontrolled infection.
- Active, uncontrolled seizure disorder (seizures in the last 6 months).
- Concurrent use of other anti-cancer agents or treatments.
- Positive for HIV or infectious hepatitis, type B or C.
- Hypersensitivity to thalidomide.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Arm A
Subjects will receive the current standard of care treatment.
Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant.
After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
|
Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Autres noms:
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Autres noms:
Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
Autres noms:
Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
Autres noms:
Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
Autres noms:
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Autres noms:
Mesna will be provided with the cyclophosphamide.
Autres noms:
|
Comparateur actif: Arm B
Subjects will receive the new treatment that will be compared with the standard of care.
Lenalidomide and dexamethasone for eight 28-day cycles.
After four cycles your stem cells will be collected (stem cell collection).
After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
|
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Autres noms:
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Autres noms:
Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
Autres noms:
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Autres noms:
Mesna will be provided with the cyclophosphamide.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Complete Response Rate
Délai: 3 years
|
The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
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3 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall Survival Rate (OS)
Délai: 4 years
|
To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms.
Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
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4 years
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Overall Survival Rate (OS)
Délai: 2 years
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To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms.
Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
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2 years
|
Progression Free Survival (PFS)
Délai: 4 years
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PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
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4 years
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Progression Free Survival (PFS)
Délai: 2 years
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PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
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2 years
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Suzanne Lentzsch, MD, Columbia University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2012
Achèvement primaire (Réel)
11 avril 2017
Achèvement de l'étude (Réel)
11 avril 2017
Dates d'inscription aux études
Première soumission
19 novembre 2012
Première soumission répondant aux critères de contrôle qualité
19 novembre 2012
Première publication (Estimation)
22 novembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 février 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Maladies hématologiques
- Troubles hémorragiques
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Myélome multiple
- Tumeurs, plasmocyte
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents anti-inflammatoires
- Agents antirhumatismaux
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Antiémétiques
- Agents gastro-intestinaux
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Adjuvants, immunologique
- Dexaméthasone
- Cyclophosphamide
- Lénalidomide
- Lénograstim
- Melphalan
Autres numéros d'identification d'étude
- AAAJ2355
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual participant data (IPD) will be coded and shared with the University of Pittsburgh at the end of the trial.
Délai de partage IPD
After completion of the study.
Critères d'accès au partage IPD
All data will be coded with study identifiers.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .