Elranatamab/Lenalidomide 통합 및/또는 Elranatamab 유지 대 이식 자격이있는 NDMM 환자의 D-VRD 유도 후 치료 표준 치료. (ElLen)
새로 진단 된 다발성 골수종 치료에 대한 3 상, 오픈 라벨, 제어, 무작위 연구, 엘라 나타 맙-레 날리도 마이드 조합의 효능 및 안전성을 화학 요법 대체로 평가 한 후 칭찬 단계에서의자가 줄기 세포 이식 및 유지 보수 단계에서 Elranatamab을 비교합니다.
This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT.
824 patients will be enrolled in this study from approximately 70 study sites.
The 2 parts in the Treatment Phase are described below.
Part 1: Induction/ASCT/Consolidation Phase (1:1 Randomization)
After the screening period, patients will be randomly allocated (1:1) to either:
- Arm A (standard of care arm): standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, D-VRd consolidation therapy
- Arm B (experimental arm): standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.
Part 2: Maintenance Phase (1:1 Re-randomization) Patients will be re-randomized (1:1) and will enter the Maintenance Phase upon completion of consolidation therapy.
• Arm C (standard of care arm): daratumumab + lenalidomide approx 2 years. Subjects with a negative MRD (for at least 12 months) after 24 cycles of daratumumab-lenalidomide will discontinue daratumumab and continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first).
Subjects who did not achieve MRD negativity for at least 12 months after 24 cycles of daratumumab-lenalidomide will continue to receive daratumumab-lenalidomide until:
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MRD negativity for at least 12 months is reached. Subjects will then continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first).
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Disease progression
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Or study cut-off date (whichever occurs first).
- Arm D (experimental arm): elranatamab. Approx 2 years. Subjects with a negative MRD (for at least 12 months) after receiving M22 administration of elranatamab will discontinue study treatment with elranatamab.
Subjects who did not achieve MRD negativity for at least 12 months after M22 elranatamab administration will continue to receive elranatamab, every 24 weeks, until MRD negativity for at least 12 months is reached, disease progression, or study cut-off date (whichever occurs first).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Juliette SEON, PharmD
- 전화번호: 0140212404
- 이메일: j.seon@myelome.fr
연구 장소
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Brussels, 벨기에, 1000
- 아직 모집하지 않음
- Institut Jules Bordet
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Brussels, 벨기에, 1200
- 아직 모집하지 않음
- Cliniques Universitaires Saint Luc
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Charleroi, 벨기에, 6000
- 아직 모집하지 않음
- Grand Hopital Charleroi
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Liège, 벨기에, 4000
- 아직 모집하지 않음
- CHU de Liège
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Yvoir, 벨기에, 5530
- 아직 모집하지 않음
- CHU UCL Namur
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Amiens, 프랑스
- 모병
- CHU Amiens
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Angers, 프랑스
- 모병
- CHU Angers
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Annecy, 프랑스
- 모병
- Ch Annecy Genevois
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Argenteuil, 프랑스
- 모병
- Centre Hospitalier d'Argenteuil Victor Dupouy
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Avignon, 프랑스
- 모병
- Centre Hospitalier H. Duffaut
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Bayonne, 프랑스
- 모병
- Centre hospitalier de la Côte Basque
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Besançon, 프랑스
- 모병
- CHU Besançon
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Blois, 프랑스
- 모병
- Centre Hospitalier Simone Veil
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Bobigny, 프랑스
- 모병
- Hôpital Avicenne
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Bordeaux, 프랑스
- 모병
- CHU Bordeaux - Hopital Haut Lévêque - Centre F. Magendi
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Bourg-en-Bresse, 프랑스
- 모병
- CH Fleyriat
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Brest, 프랑스
- 모병
- CHRU Brest - Hôpital A. Morvan
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Caen, 프랑스
- 모병
- CHU Caen - Côte de Nacre
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Chalon-sur-Saône, 프랑스
- 모병
- Centre Hospitalier William Morey
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Chambéry, 프랑스
- 모병
- CHMS Centre Hospitalier Métropole Savoie
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Chartres, 프랑스
- 모병
- Hopital Louis Pasteur
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Clamart, 프랑스
- 모병
- Hôpital d'Instruction des Armées Percy
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Clermont-Ferrand, 프랑스
- 모병
- Chu Estaing
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Corbeil-Essonnes, 프랑스
- 모병
- Centre Hospitalier Sud Francilien
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Créteil, 프랑스
- 모병
- CHU Henri Mondor
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Dijon, 프랑스
- 모병
- CHU Dijon
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Dijon, 프랑스
- 모병
- Institut de cancérologie de Bourgogne
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Dunkirk, 프랑스
- 모병
- Centre Hospitalier de Dunkerque
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Grenoble, 프랑스
- 모병
- CHU de Grenoble
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La Roche-sur-Yon, 프랑스
- 모병
- CHD Vendée
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La Réunion, 프랑스
- 모병
- CHU de la Réunion Site SUD (Terre Sainte)
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Le Havre, 프랑스
- 모병
- Hopital Monod
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Le Mans, 프랑스
- 모병
- CH Le mans
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Lille, 프랑스
- 모병
- CHRU Hôpital Claude Huriez
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Limoges, 프랑스
- 모병
- Centre Hospitalier Universitaire (CHU) de Limoges
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Lyon, 프랑스, 69373
- 모병
- Centre Léon Bérard
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Lyon, 프랑스
- 모병
- Centre Hospitalier Lyon Sud
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Meaux, 프랑스
- 모병
- Grand Hopital Est Francilien (GHEF) Site de Meaux
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Metz, 프랑스
- 모병
- Hôpital de Mercy (CHR Metz-Thionville)
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Mont-de-Marsan, 프랑스
- 모병
- Centre de Recherche Clinique / GHT des Landes
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Montpellier, 프랑스
- 모병
- Hopital Saint Eloi - CHU Montpellier
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Mulhouse, 프랑스
- 모병
- Hôpital E. Muller
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Nancy, 프랑스
- 모병
- CHRU Hôpitaux de Brabois
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Nantes, 프랑스
- 모병
- CHRU Hôtel Dieu
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Nice, 프랑스
- 모병
- Hôpital Archet 1
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Nîmes, 프랑스
- 모병
- CHU Carémeau, Institut de Cancérologie du Guard
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Orléans, 프랑스
- 모병
- CHR Orléans
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Paris, 프랑스
- 모병
- Hôpital Cochin
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Paris, 프랑스
- 모병
- CHU Hôpital Saint Antoine
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Paris, 프랑스
- 모병
- Hôpital Necker
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Paris, 프랑스
- 모병
- Hôpital Saint Louis
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Paris, 프랑스
- 모병
- La Pitié Salpêtrière
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Perpignan, 프랑스
- 모병
- CH Saint Jean
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Poitiers, 프랑스
- 모병
- CHU Poitiers - Pôle régional de Cancérologie
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Pontoise, 프랑스
- 모병
- Centre hospitalier René Dubost
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Périgueux, 프랑스
- 모병
- Centre Hospitalier de Perigueux
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Quimper, 프랑스
- 모병
- Centre Hospitalier de Quimper Cornouaille
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Rennes, 프랑스
- 모병
- CHRU Hôpital de Pontchaillou
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Rouen, 프랑스
- 모병
- Centre Henri Becquerel
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Saint-Brieuc, 프랑스
- 모병
- Centre Hospitalier Saint Brieuc
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Saint-Priest, 프랑스
- 모병
- Institut de Cancérologie Lucien Neuwirth
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Saint-Quentin, 프랑스
- 모병
- Centre Hospitalier de Saint-Quentin
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Strasbourg, 프랑스
- 모병
- CHU Strasbourg
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Tarbes, 프랑스
- 모병
- Centre hospitalier
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Toulouse, 프랑스
- 모병
- Pôle IUCT Oncopole CHU
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Tours, 프랑스
- 모병
- CHRU Hôpital Bretonneau - Centre Henry Kaplan
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Vannes, 프랑스
- 모병
- CH Bretagne Atlantique Vannes et Auray - P. Chubert
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Versailles, 프랑스
- 모병
- CHV André Mignot - Université de Versailles
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Villejuif, 프랑스
- 모병
- Gustave Roussy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Male or female subjects, aged over 18 but < 70 years old
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Patients have provided voluntary written informed consent before performing any study-related procedure.
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Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT).
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Patients with documented symptomatic NDMM according to CRAB and/or SLIM criteria, with measurable disease as defined by:
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Presence of ≥10% monoclonal plasma cells in the bone marrow OR presence of a biopsy-proven plasmacytoma. In addition, the patient must have ≥1 of the following myeloma defining events:
- Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than upper limits of normal (ULN) or >2.75 mmol/L (>11 mg/dL).
- Renal insufficiency: creatinine clearance < 40mL/min/1.73 m2 using CKD-EPI or serum creatinine >177 μmol/L (>2 mg/dL).
- Anemia: hemoglobin >2 g/dL below the lower limit of normal (LLN) or hemoglobin <10 g/dL.
- Bone lesions: ≥1 osteolytic lesion on skeletal radiography, CT or PET-CT.
- Clonal bone marrow plasma cell percentage ≥60%.
- Serum involved/uninvolved free light chain ratio ≥100.
- More than 1 focal lesion (≥5 mm diameter) on MRI.
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Measurable disease as defined by serum M-component ≥5 g/L, and/or urine M-component ≥200 mg/24 h and/or serum FLC ≥100 mg/L.
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Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
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Patients must have clinical laboratory values (within 15 days of initiating induction therapy) as follows:
• Hemoglobin ≥7.5 g/dL (≥5 mmol/L). Prior red blood cell (RBC) transfusion or the use of recombinant human erythropoietin is permitted.
• Absolute neutrophil count (ANC) ≥1.0 G/L (granulocyte colony stimulating factor [G-CSF] use is permitted).
• Aspartate aminotransferase (AST) ≤3 x ULN.
• Alanine aminotransferase (ALT) ≤ 3 x ULN.
• Total bilirubin ≤3 x ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome, that require a direct bilirubin ≤3 x ULN).
• Calculated creatinine clearance ≥40 mL/min/1.73 m².
- Albumin corrected serum calcium ≤14 mg/dL (<3.5 mmol/L); or free-ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L).
- Platelet count ≥50 Giga/L for subjects who have <50% of bone marrow nucleated cells as plasma cells. If not, platelet count >30 G/L (platelets transfusions done during the 15 days before initiating induction therapy are not permitted).
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Women of childbearing potential must have a negative serum or urine pregnancy test during the screening period before randomization AND within 3 days before of initiating induction therapy.
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Patients must be willing and able to comply with scheduled appointments, treatment plan, laboratory tests, and other study procedures (such as blood transfusion if required, ASCT, IVIG prophylaxis, etc.).
Exclusion Criteria:
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Subjects previously treated with any systemic therapy for multiple myeloma. Patients are allowed corticosteroids before or during screening, as far as the total dose received is not >160 mg of dexamethasone (or equivalent) within 14 days before initiating induction therapy. Patients with concurrent radiotherapy within the 14 days before initiating induction therapy are not eligible (If possible, in these cases, enrolment should be deferred).
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Subject with ongoing Grade ≥ 3 peripheral sensory or motor neuropathy.
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Subject with history of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
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Subject with a current diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or solitary plasmacytoma.
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Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
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The subject has had plasmapheresis within 14 days of initiating induction therapy.
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Subject with clinical signs of meningeal involvement of multiple myeloma.
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The subject has plasma cell leukemia (by WHO criterion: ≥5% of plasma cells in the peripheral blood) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
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Subject has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
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Subject has clinically significant cardiac disease, including:
• Subject has had myocardial infarction within 1 year before initiating induction therapy, or currently has an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association [NYHA] class III IV).
- Subject has uncontrolled cardiac arrhythmia (common terminology criteria for adverse events [CTCAE] version 4 grade ≥2) or clinically significant electrocardiography (ECG) abnormalities.
- Subject with a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec (12-lead ECG).
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Subjects taking systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort (millepertuis) within the 14 days before initiating induction therapy.
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Known intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
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Known allergies to any of the study medications, their analogues, or excipients in the various formulations.
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Subjects who have had major surgery within 2 weeks before study inclusion (signing of the informed consent) OR will not have fully recovered from surgery before initiating induction therapy OR have surgery planned during their study participation. Kyphoplasty and vertebroplasty are not considered as major surgery.
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Subjects with any prior or concurrent malignancy (other than multiple myeloma) within 5 years of study inclusion study, except for adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or localized prostate adenocarcinoma diagnosed ≥3 years ago and without evidence of biological failure, or other cancers for which the subject has undergone potentially curative therapy and has without evidence of relapse/recurrence for ≥5 years.
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Pregnant or breast-feeding women.
Women that refuse to abstain from heterosexual intercourse or refuse to use adequate contraceptives during heterosexual intercourse starting at least 4 weeks before initiating induction therapy and continually until at least 4 weeks after discontinuing lenalidomide,90 days after discontinuing daratumumab and 6 months after discontinuing elranatamab.
18. Men with partners of childbearing potential, even men with a successful vasectomy, that refuse to use a condom during intercourse, from initiating induction therapy to ≥4 weeks ys after discontinuing lenalidomide,. Furthermore, men must agree to not donate sperm during this period.
19. Known positive for HIV or active hepatitis A, B or C: Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA
Of note:
Patients can be eligible if anti-HBc IgG positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative.
o If anti-HBV therapy in relation to prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period.
Patients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative, and all the other study criteria are still met.
• Active HCV infection: positive HCV RNA and negative anti-HCV.
Of note:
Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion.
Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible.
20. Patient with an active systemic infection or severe infections requiring parenteral administration of antibiotics.
21. Patients with a gastrointestinal disease/disorder that may significantly impact the absorption of oral treatments.
22. Patients unable or unwilling to undergo antithrombic prophylaxis.
23. A person under guardianship, trusteeship, or deprived of freedom by a judicial or administrative decision.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: D-VRD induction, ASCT and D-VRD consolidation (arm A)
Standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, and 2 cycles of D-VRd consolidation therapy |
In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C) Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A ASCT is performed in consolidation for Arm A patients after induction therapy with D-VRD Bortezomib is given in associtaion with daratumumab, lenalidomide and dexamethasone in induction (all patients) and consolidation Arm A Dexamethasone is given in association with daratumumab, bortezomib and lenalidomide in induction (all patients) and consolidation Arm A |
|
실험적: D-VRD induction followed by elranatamab and lenalidomide consolidation (arm B)
Standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy. |
In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C) Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A Bortezomib is given in associtaion with daratumumab, lenalidomide and dexamethasone in induction (all patients) and consolidation Arm A Dexamethasone is given in association with daratumumab, bortezomib and lenalidomide in induction (all patients) and consolidation Arm A Elranatamab is given to arm B patients in association with lenalidomide (for consolidation) and arm D patients in monotherapy (for maintenance) as experimental arms |
|
활성 비교기: daratumumab + lenalidomide maintenance (Arm C)
Daratumumab + Lenalidomide for two years (maintenance) |
In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C) Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A |
|
실험적: elranatamab maintenance (Arm D)
Elranatamab monotherapy for two years (maintenance) |
Elranatamab is given to arm B patients in association with lenalidomide (for consolidation) and arm D patients in monotherapy (for maintenance) as experimental arms |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1 (induction/consolidation) from Randomization 1 (R1): to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Minimal Residual Disease (MRD) negativity rate
기간: at end of consolidation, up to 36 months
|
To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of MRD negativity rate. |
at end of consolidation, up to 36 months
|
|
Part 2 (maintenance) from Randomization 2 (R2): to assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of Progression Free Survival (PFS).
기간: from the date of second randomization to the date of confirmed PD (IMWG criteria,) or death from any cause, whichever came first, assessed up to 93 monts
|
To assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of PFS. |
from the date of second randomization to the date of confirmed PD (IMWG criteria,) or death from any cause, whichever came first, assessed up to 93 monts
|
|
Key secondary objectives: Part 1 (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS
기간: PFS defined as the time interval from the date of first randomization to the date of confirmed Progression Disease (IMWG criteria) or death from any cause, whichever occurs first., assessed up to 128 months
|
To assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS |
PFS defined as the time interval from the date of first randomization to the date of confirmed Progression Disease (IMWG criteria) or death from any cause, whichever occurs first., assessed up to 128 months
|
|
Key secondary objectives: Part I (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Overal Survival (OS)
기간: up to 128 months
|
To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of OS |
up to 128 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1 (induction/consolidation) from R1: to assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care
기간: End of consolidation phase, up to 36 months
|
To assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care: Overall response rate (ORR), Very good partial response (VGPR) rate, Complete response (CR) rate |
End of consolidation phase, up to 36 months
|
|
Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab
기간: end of maintenance, up to 58 months
|
To assess the efficacy of maintenance therapy with elranatamab:
|
end of maintenance, up to 58 months
|
|
assess safety & Tolerability during induction, and during consolidation and maintenance therapy: Adverse events (AE), serious Adrverse events (SAE) and And adverse events of special interest (AESI) rates - Incidence of Treatment-Emergent Adverse Events
기간: through study completion, up to 128 months
|
To assess safety during induction, and during consolidation and maintenance therapy: AEs, SAE and AESI rates , Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
through study completion, up to 128 months
|
|
Throughout the study to evaluate the impact of treatment on health-related Quality of Life (QoL) using Rework questionnaire
기간: through study completion, up to 128 months
|
To evaluate the impact of treatment on health-related QoL: Rework questionnaire |
through study completion, up to 128 months
|
|
Part 2 (maintenance) from Randomization 2 (R2): to assess the efficacy of maintenance therapy with elranatamab, Progression Free Survival 2 form Randomization 2
기간: up to 128 months
|
To assess the efficacy of maintenance therapy with elranatamab: - PFS of subsequent/next treatment line (PFS2 from R2) |
up to 128 months
|
|
Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab, in term of Minimal Residual Disease negativity
기간: 12 months post R2, up to 71 months
|
To assess the efficacy of maintenance therapy with elranatamab: - MRD negativity at 12 months post R2 |
12 months post R2, up to 71 months
|
|
Throughout the study: to evaluate the impact of treatment on health-related Quality of Life (QoL) using EQ-5D-5L
기간: Though study completion, an average of 11 years
|
To evaluate the impact of treatment on health-related QoL: scale title :EQ-5D-5L , the minimum value is 0 and maximum value is 100 (100 corresponds to the best health that patient can imagine, 0 corresponds to the worst health that patient can imagine |
Though study completion, an average of 11 years
|
|
Part 2 (maintenance) from R2: To assess the efficacy of maintenance therapy with elranatamab (OS R2)
기간: up to 128 months
|
To assess the efficacy of maintenance therapy with elranatamab: - Overall survival from second randomization (OS R2) |
up to 128 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EXPLORATORY OBJECTIVES: to assess the impact of genomic markers (from Next generation sequencing (NGS) and Whole Genome Sequencing (WGS)) on outcome
기간: up to 128 months
|
To assess the impact of genomic markers (from NGS and WGS) on outcome: MRD negativity rate as determined by NGS with a sensitivity of at least 10-5 - PFS1 and OS |
up to 128 months
|
|
EXPLORATORY OBJECTIVES: to assess Immune mechanisms predicting Elra-Len vs ASCT efficacy
기간: up to 128 months
|
Impact of the microenvironment (Immune mechanisms predicting Elra-Len vs ASCT efficacy) according to outcome (MRD, PFS and OS) rates |
up to 128 months
|
|
EXPLORATORY OBJECTIVES: to assess the impact of PET imaging parameters/variables on outcome
기간: End of consolidation phase, up to 36 months
|
rate of PET imaging positive / negative according to outcome (MRD, PFS and OS) rates |
End of consolidation phase, up to 36 months
|
|
EXPLORATORY OBJECTIVES: To determine influence of M-component measurement assessed by mass spectrometry on outcome
기간: up to 128 months
|
To determine influence of M-component measurement assessed by mass spectrometry on outcome |
up to 128 months
|
|
EXPLORATORY OBJECTIVES: To determine influence of circulating tumor cells on outcome in term of PFS1 and OS
기간: up to 128 months
|
To determine influence of circulating tumor cells on outcome in term of PFS1 and OS |
up to 128 months
|
|
Exploratory objective :To evaluate the pharmacokinetics (PK) of elranatamab
기간: up to 128 months
|
Predose and postdose concentrations of elranatamab |
up to 128 months
|
|
Exploratory objective : To evaluate the immunogenicity of elranatamab
기간: up to 128 months
|
To evaluate the immunogenicity of elranatamab |
up to 128 months
|
|
Exploratory objective :To explore correlations between elranatamab exposure and efficacy, safety and biomarker endpoints, if data allow
기간: up to 128 months
|
To explore correlations between elranatamab exposure and efficacy, safety and biomarker endpoints, if data allow |
up to 128 months
|
|
exploratory objective : assess treatment discontinuation rates
기간: up to 128 months
|
To assess treatment discontinuation rates |
up to 128 months
|
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Chanaz LOUNI, The Institute for Functional Medicine
- 수석 연구원: Aurore PERROT, Prof, IUCT Toulouse France
- 수석 연구원: Cyrille TOUZEAU, Prof, CHU Nantes France
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 혈관 질환
- 심혈관 질환
- 신생물
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 혈액 질환
- 림프 증식 장애
- 면역증식성 장애
- 신생물, 형질세포
- 지혈 장애
- 파라단백혈증
- 혈액 단백질 장애
- 출혈성 장애
- 헴 및 림프병
- 다발성 골수종
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 카르 복실 산
- 다 환식 화합물
- 파이퍼 리딘
- 무기 화학 물질
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 스테로이드, 불소
- Pregnadienetriols
- 보 론산
- 산, 비 카르 복실
- 산
- 붕소 화합물
- 피라진
- 프탈리 미드
- 프탈산
- 산, 카르 보 사이 클릭
- 파이퍼리돈
- Isoindoles
- 레날리도마이드
- 보르테조밉
- 덱사메타손
- 다라 토무 맙
기타 연구 ID 번호
- IFM 2025-01
- 2024-516418-39-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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