Actively Recruiting
Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)
Led by PETHEMA Foundation · Updated on 2025-08-01
30
Participants Needed
10
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if anitocabtagene autoleucel following induction therapy works to treat adult participants with newly diagnosed multiple myeloma. The main objectives of this clinical trial are: * To determine the incidence and severity of all adverse events (AEs). * To determine the proportion of patients achieving undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10 to -5) at 12 months (+/- 3 months) after enrollment. Participants will receive induction therapy with a quadruplet regimen including a proteasome inhibitor (Bortezomib \[V\]), immunomodulatory drug (Lenalidomide \[R\]), dexamethasone \[d\] and anti-CD38 monoclonal antibody (Daratumumab \[D\] or Isatuximab \[Isa\]) followed by anitocabtagene autoleucel. Participants in Cohorts A and B will receive lenalidomide maintenance therapy following infusion with anitocabtagene autoleucel.
CONDITIONS
Official Title
Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed Multiple Myeloma according to IMWG 2014 criteria
- For cohort A, age 70 years or younger
- For cohorts B and C, age 80 years or younger
- Measurable disease at screening as defined by serum or urine M-protein or serum free light chain levels
- Candidates for D-VRd or Isa-VRd induction regimens
- Male or female aged 18 years or older with capacity to give informed consent
- ECOG performance status of 0 or 1
- Adequate hematological function with specified minimum counts and coagulation parameters
- Adequate renal, hepatic, pulmonary, and cardiac function meeting defined thresholds
- Females of childbearing potential must have a negative pregnancy test
- Willingness and ability to comply with study procedures including long-term safety follow-up
You will not qualify if you...
- Active or prior central nervous system or meningeal involvement of multiple myeloma
- Cardiac atrial or ventricular involvement by multiple myeloma
- Diagnosis of primary amyloidosis, MGUS, smoldering multiple myeloma, plasma cell leukemia, active POEMS syndrome, or Waldenstrom's macroglobulinemia
- Active malignancy other than multiple myeloma requiring treatment within last 24 months, with some curatively treated exceptions
- Prior systemic anti-myeloma treatment or radiotherapy before enrollment (except limited palliative treatments)
- Prior allogeneic stem cell transplant
- Live vaccine within 4 weeks before enrollment or planned during study
- Uncontrolled or systemic infection requiring IV antimicrobials
- Active hepatitis A, B, or C infection
- HIV positive status
- COPD with FEV1 below 50% if receiving anti-CD38 antibody combination
- Significant cardiac disease or recent events within 6 months
- History of intracranial or CNS disorders or recent stroke or seizure disorders
- Peripheral neuropathy Grade 3 or higher
- History of solitary plasmacytoma
- Autoimmune diseases requiring systemic immunosuppression within 2 years
- Genetic syndromes associated with bone marrow failure
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- Presence of indwelling lines or drains except certain central venous catheters
- Major surgery within 28 days before enrollment or planned during study
- Medical, neurological, or psychiatric conditions interfering with study
- Pregnancy or breastfeeding
- Unwillingness to use effective birth control during required periods
- Contraindication to fludarabine or cyclophosphamide
- Allergy or hypersensitivity to study drugs or components including severe reaction to DMSO
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Hospital Germans Trias i Pujol (ICO BADALONA)
Badalona, Spain
Actively Recruiting
2
H. Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
3
H. 12 de Octubre
Madrid, Spain
Actively Recruiting
4
H. Ramón y Cajal
Madrid, Spain
Actively Recruiting
5
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
6
Hospital Clinico Universitario Salamanca
Salamanca, Spain, 37007
Actively Recruiting
7
H. Marqués de Valdecilla
Santander, Spain
Actively Recruiting
8
C H Santiago de Compostela
Santiago de Compostela, Spain
Actively Recruiting
9
Complejo Hosp. Regional Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
10
Hospital Universitario y Politécnico La Fe de Valencia
Valencia, Spain
Actively Recruiting
Research Team
C
Carmen López-Carrero
CONTACT
R
Roberto Maldonado
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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