CILTACABTAGENE AUTOLEUCEL for Newly diagnosed multiple myeloma | Multiple myeloma

Inclusion criteria

• {"criterion_text":"- 1. At the time of informed consent, be ≥18 years of age (or at least the legal age of consent in the jurisdiction in which the study is taking place) but ≤80 years of age.\n- 2. Documented diagnosis of NDMM according to the most recent IMWG diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy)\n- 3. Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: -Advanced age; or -Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or -Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment.\n- 4. Participant must have received 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.Participants must have achieved ≥PR to be enrolled on the most recent disease assessment.\n- 5. ECOG Performance Status score of 0 or 1\n- 6. Clinical laboratory values as defined in the protocol"}

Exclusion criteria

• {"criterion_text":"- 1. Prior systemic therapy for multiple myeloma or smoldering myeloma other than VRd, DRd or DVRd as per inclusion 4a and short course of corticosteroids . For participants who require emergency treatment, refer to protocol Section 4.4.\n- 2. Radiation therapy for treatment of plasmacytoma within 14 days before enrollment. Palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of enrollment, if the radiation portal covered ≤5% of the bone marrow reserve\n- 3. Frailty index of ≥ 2 according to Myeloma Geriatric Assessment score\n- 4. The following cardiac conditions: - New York Heart Association stage III or IV congestive heart failure. - Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment. - History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration. - History of severe non-ischemic cardiomyopathy. - Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition scan (performed ≤60 days prior to apheresis).\n- 5. Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib.\n- 6. Participants who require continuous supplemental oxygen."}

Primary endpoints

• {"endpoint_text":"- MRD-negative CR at 12 months after cilta-cel infusion with a sensitivity of 10^-5","definition_or_measurement_approach":"MRD-negative complete response at 12 months after cilta-cel infusion assessed using an MRD assay with sensitivity 10^-5 (i.e. MRD negativity defined at sensitivity of 10^-5)."}

Spain

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

160

Number Of Sites

8

Number Of Participants

33

Primary sponsor

Full Name

Janssen Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties code: 6 (as listed in CTIS third parties)

Name

4g Clinical LLC

Responsibilities

sponsorDuties code: 3 (as listed in CTIS third parties)

Name

Cerba Research

Responsibilities

sponsorDuties code: 4 (laboratory/testing services)

Name

Labcorp Central Laboratory Services SARL

Responsibilities

sponsorDuties code: 4 (laboratory/testing services)

Third parties

• {"country":"Germany","full_name":"CMT Cellex Manufacturing Transports and Logistics GmbH","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"sponsorDuties code: 15; value: Ancillary Supplies","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}