Cilta‑cel with a fludarabine‑free or alternative lymphodepletion plan for multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives cilta‑cel (a CAR‑T cell therapy) to patients with newly diagnosed, measurable multiple myeloma who are not candidates for high‑dose chemotherapy with stem cell transplant. Participants receive cilta‑cel either after a fludarabine‑free lymphodepletion regimen or following cyclophosphamide plus fludarabine with an alternative infusion timing. The study measures response rates and safety outcomes to compare efficacy and tolerability of the different lymphodepletion approaches. It is sponsored by Janssen and conducted at several US cancer centers.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting
• Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
  Winston-Salem, North Carolina, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Royal Prince Alfred Hospital
  Camperdown, Australia Recruiting
• Monash Medical Centre
  Clayton, Australia Recruiting
• Austin Hospital
  Heidelberg, Australia Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.