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RecruitingLast updated: 14 November 2025

CARTITUDE-10: Comparing different methods to lower levels of immune cells before giving CAR T-cell immunotherapy, to see which works best, in people with newly diagnosed multiple myelomaA Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 80

Trial acronym

CARTITUDE-10

Clinical summary

Summary

Cilta-cel is a type of immunotherapy called CAR T-cell therapy, which is typically administered after immune cells (lymphocytes) are reduced in the body through chemotherapy.

The study is assessing how well cilta-cel works when it's given after two different ways of lowering the immune cells (lymphodepletion): with a combination of chemotherapies (cyclophosphamide and fludarabine) or just one chemotherapy (cyclophosphamide).

You may be eligible if you have newly diagnosed multiple myeloma and have received at least 3 cycles, and no more than 5 cycles, of induciton therapy (DRd, VRd or DVRd).

 

Participants in the study will be allocated to one of two treatment groups, called Cohorts.

All participants will continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd) that they were receiving prior to screening for this study.

After the completion of induction therapy, participants will either receive a conditioning regimen of cyclophosphamide (Cohort A) or cyclophosphamide and fludarabine (Cohort B) daily for 3 days as intravenous (IV) infusions, followed by Ciltacel IV infusion on Day 1.

Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

Conditions

This trial is treating people with multiple myeloma

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT07149857 *
  • 68284528MMY2012; 68284528MMY2012; 2025-521975-30-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

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

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