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Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

RecruitingPhase 2Ages 18 Years - 80 YearsAllPETHEMA Foundation
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if anitocabtagene autoleucel following induction therapy works to treat adult participants with newly diagnosed multiple myeloma. The main objectives of this clinical trial are: * To determine the incidence and severity of all adverse events (AEs). * To determine the proportion of patients achieving undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10 to -5) at 12 months (+/- 3 months) after enrollment. Participants will receive induction therapy with a quadruplet regimen including a proteasome inhibitor (Bortezomib \[V\]), immunomodulatory drug (Lenalidomide \[R\]), dexamethasone \[d\] and anti-CD38 monoclonal antibody (Daratumumab \[D\] or Isatuximab \[Isa\]) followed by anitocabtagene autoleucel. Participants in Cohorts A and B will receive lenalidomide maintenance therapy following infusion with anitocabtagene autoleu

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Newly diagnosed Multiple Myeloma according to the IMWG criteria published in 2014. 1. For cohort A, patients will ≤ 70 years of age. 2. For the cohorts B and C, patients will be ≤ 80 years of age. 2. Measurable disease at screening per IMWG, defined as any of the following: 1. Serum M-protein level ≥ 1 g/dL or urine M-protein level ≥ 200 mg/24 hours; or 2. Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio. * Note: Local laboratory results may be used to establish measurable disease at screening if the results are ≥ 125% of requirements. 3. Only participants who are candidates to receive either D-VRd or Isa-VRd induction regimens, as determined by the investigator, should be considered for this study. 4. Male or female aged 18 years or older and has capacity to give informed consent. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Adequate hematological function defined as the following: * Hemoglobin count ≥ 7.5 g/dL (without any red blood cell \[RBC\] transfusion within 7 days prior to the test result; use of recombinant human erythropoietin is permitted). * Absolute neutrophil count (ANC) ≥ 500/μL (without non-PEGylated myeloid growth factor support within 7 days or PEGylated myeloid growth factor support within 14 days prior to the test result). * Platelet count ≥ 75,000/μL (unless secondary to bone marrow or spleen involvement of MM, in which platelet count ≥ 50,000/μL is permitted) without any platelet cell transfusion within 7 days prior to the test result. Bone marrow involvement by MM is demonstrated by bone marrow aspiration or biopsy. Spleen involvement by MM is demonstrated by splenomegaly. * Absolute lymphocyte count (ALC) ≥ 100/μL. * PTT/PT/INR \< 1.5x upper limit of normal (ULN), unless on a stable dose of anticoagulant for a thromboembolic even (subjects with a history of thromboembolic stroke or history of Grade 2 or greater hemorrhage within 1 year are excluded. 7. Adequate renal, hepatic, pulmonary, and cardiac function defined as the following: * Estimated glomerular filtration rate (eGFR) (as estimated by Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation \[Section 12.14\]) ≥ 45 mL/min. * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN. * Total bilirubin ≤ 1.5 mg/dL, except in participants with Gilbert's syndrome or documented MM liver or pancreatic involvement where ≤ 3 x ULN is permitted. * Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion as determined by echocardiogram (ECHO). Multigated acquisition (MUGA) scan may be used if an ECHO is not available at the site. * No evidence of Grade 2 or higher (per National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5.0) pleural effusion or ascites (participants with Grade 1 pleural effusion or ascites are eligible). * Baseline oxygen saturation \>92% on room air. 8. Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential; refer to Section 12.2). 9. Willing to comply with and able to tolerate study procedures, including consent to participate in separate Long-term Safety Follow-up lasting up to 15 years per authorities´ guidance. Exclusion Criteria: 1. Active or prior history of central nervous system (CNS) or meningeal involvement of MM. 2. Cardiac atrial or cardiac ventricular MM involvement. 3. Diagnosis of primary amyloidosis (AL), monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia (PCL), active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or Waldenstrom's macroglobulinemia at the time of screening. 4. Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted. Allowed malignancy exceptions are: 1. Localized skin cancer (melanoma and nonmelanoma) that has been completely resected and considered curative within the last 24 months is eligible. 2. Cervix carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible. 3. Bladder carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible. 4. Breast carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible. Hormonal therapy after curative-intent treatment is permitted. 5. Prostate cancer that is low grade and localized (Grade Group 1, has not spread to nearby lymph nodes \[N0\] or metastasized \[M0\]) within the last 24 months is eligible, including cases under surveillance only as part of standard of care. Androgen deprivation therapy is permitted. 6. Localized renal cell carcinoma (≤ Stage 2) that has been completely resected and considered curative within the last 24 months is eligible. 7. Localized (Stage 1) colorectal cancer that has been completely resected and considered curative (without need for adjuvant chemotherapy) within the last 24 months is eligible. 5. Any prior systemic anti-myeloma treatment (including BCMA-directed treatment) and/or radiotherapy before enrollment. Palliative radiation and corticosteroids (up to cumulative dose of 160mg prednisone or equivalent, and not requiring ongoing therapy) prior to enrollment are permitted. Participants must have recovered from all radiation-related toxicities. Patients with radiation-induced lung injury (RILI,
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What it tests

  • Daratumumab
  • Isatuximab
  • Bortezomib
  • Lenalidomide
  • Cyclophosphamide
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Where

10 sites
Hospital Germans Trias i Pujol (ICO BADALONA)
Badalona, Spain
H. Clinic de Barcelona
Barcelona, Spain
H. 12 de Octubre
Madrid, Spain
H. Ramón y Cajal
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Clinico Universitario Salamanca
Salamanca, Spain
H. Marqués de Valdecilla
Santander, Spain
C H Santiago de Compostela
Santiago de Compostela, Spain

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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