Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients

Multiple myeloma (MM) is a malignant disease of the BM characterized by clonal expansion of plasma cells. Current guidelines recommend that newly diagnosed transplant-eligible patients with multiple myeloma (NDMMTE) shall undergo several cycles of induction, followed by one or two cycles high-dose melphalan followed by autologous stem cell transfusion (ASCT). Currently, induction therapy schemes usually consist of an immunomodulator (thalidomide or lenalidomide), a transmembrane glycoprotein CD38 targeting antibody, a proteasome inhibitor, and dexamethasone. The induction therapy is then follo

Trial Details

NCT ID
NCT05665140
Phase
PHASE2 / PHASE3
Sponsor
University Hopsital Schleswig Holstein Campus Lübeck
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Isatuximab
  • Lenalidomide
  • Bortezomib
  • Dexamethasone
  • autologous stem cell transplant
Locations (sample)
  • Berlin, Germany|52.52437,13.41053
  • Bielefeld, Germany|52.03333,8.53333
  • Hamburg, Germany|53.55073,9.99302
  • Lübeck, Germany|53.86893,10.68729
  • Münster, Germany|51.96236,7.62571

Key Eligibility Criteria

  • newly diagnosed, untreated, symptomatic, documented myeloma (according to the revised Hypercalcaemia, renal dysfunction, anaemia and bone lesions (…
  • IV. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET- CT (positron emission tomography) V. Clonal BM plasma cell pe…
  • Presence of measurable disease:
  • I. Serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours. II. Involved FLC (free light chain) level ≥ 10 mg/dl, provided sFLC (free light…

For full eligibility, visit ClinicalTrials.gov.

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