A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

a study on Multiple Myeloma

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Anupama Kumar (ucsf)

Description

Summary

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

Official Title

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

Keywords

Multiple Myeloma, Cyclophosphamide, Neoadjuvant Therapy, fludarabine, Cilta-cel, Induction therapy

Eligibility

You can join if…

Open to people ages 18-80

  • Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (>=)1.0 grams per deciliter (g/dL) or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain >= 10 mg/dL and abnormal serum free light chain ratio
  • Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment
  • Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved >= partial response (PR) on the most recent disease assessment to be enrolled
  • Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1
  • Must be willing and able to adhere to the lifestyle restrictions specified in the protocol

You CAN'T join if...

  • Frailty index of >= 2 according to Myeloma Geriatric Assessment score
  • Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
  • Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
  • Participants who require continuous supplemental oxygen

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of Iowa Hospital and Clinics in progress, not accepting new patients
    Iowa City Iowa 52242 United States
  • Cleveland Clinic accepting new patients
    Cleveland Ohio 44195 United States

Lead Scientist at University of California Health

  • Anupama Kumar (ucsf)
    Dr. Kumar is hematologist/oncologist who specializes in taking care of patients with hematological malignancies. She completed medical school training and residency at Tufts Medical Center, and hematology/oncology fellowship at University of California, San Diego. She received specialized training through the bone marrow transplant track during her final year of fellowship.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT07149857
Phase
Phase 2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated
Contact us about this trial