Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function

Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal function, leading to an urgent, unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population. In addition, renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations. Thi

Trial Details

NCT ID
NCT06623630
Phase
PHASE1
Sponsor
Washington University School of Medicine
Status
RECRUITING
Cancer Type
Relapsed/Refractory Multiple Myeloma
Interventions
  • Cyclophosphamide
  • Ciltacabtagene Autoleucel
  • Total body irradiation
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Histologically confirmed diagnosis of multiple myeloma.
  • Renal insufficiency, defined as eGFR \< 45 by MDRD formula.
  • At least 18 years of age.
  • ECOG performance status ≤ 1.

For full eligibility, visit ClinicalTrials.gov.

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