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De Novo Multiple MyelomaPhase 2GEM-AnitoFIRSTNCT07045909

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

A Phase 2 study testing Daratumumab, Isatuximab and Bortezomib in people with De Novo Multiple Myeloma and Anitocabtagene Autoleucel, run by PETHEMA Foundation at 10 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Daratumumab, Isatuximab and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
10 sitesSpain
Study dates
30 Jun 2025to 31 Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed Multiple Myeloma according to the IMWG criteria published in 2014.
  • For cohort A, patients will ≤ 70 years of age.
  • For the cohorts B and C, patients will be ≤ 80 years of age.
  • Measurable disease at screening per IMWG, defined as any of the following:
  • Serum M-protein level ≥ 1 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
  • Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio.
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  • Note: Local laboratory results may be used to establish measurable disease at screening if the results are ≥ 125% of requirements.
  • Only participants who are candidates to receive either D-VRd or Isa-VRd induction regimens, as determined by the investigator, should be considered for this study.
  • Male or female aged 18 years or older and has capacity to give informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematological function defined as the following:
  • Hemoglobin count ≥ 7.5 g/dL (without any red blood cell [RBC] transfusion within 7 days prior to the test result; use of recombinant human erythropoietin is permitted).
  • Absolute neutrophil count (ANC) ≥ 500/μL (without non-PEGylated myeloid growth factor support within 7 days or PEGylated myeloid growth factor support within 14 days prior to the test result).
  • Platelet count ≥ 75,000/μL (unless secondary to bone marrow or spleen involvement of MM, in which platelet count ≥ 50,000/μL is permitted) without any platelet cell transfusion within 7 days prior to the test result. Bone marrow involvement by MM is demonstrated by bone marrow aspiration or biopsy. Spleen involvement by MM is demonstrated by splenomegaly.
  • Absolute lymphocyte count (ALC) ≥ 100/μL.
  • PTT/PT/INR < 1.5x upper limit of normal (ULN), unless on a stable dose of anticoagulant for a thromboembolic even (subjects with a history of thromboembolic stroke or history of Grade 2 or greater hemorrhage within 1 year are excluded.
  • Adequate renal, hepatic, pulmonary, and cardiac function defined as the following:
  • Estimated glomerular filtration rate (eGFR) (as estimated by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation [Section 12.14]) ≥ 45 mL/min.
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
  • Total bilirubin ≤ 1.5 mg/dL, except in participants with Gilbert's syndrome or documented MM liver or pancreatic involvement where ≤ 3 x ULN is permitted.
  • Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion as determined by echocardiogram (ECHO). Multigated acquisition (MUGA) scan may be used if an ECHO is not available at the site.
  • No evidence of Grade 2 or higher (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0) pleural effusion or ascites (participants with Grade 1 pleural effusion or ascites are eligible).
  • Baseline oxygen saturation >92% on room air.
  • Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential; refer to Section 12.2).
  • Willing to comply with and able to tolerate study procedures, including consent to participate in separate Long-term Safety Follow-up lasting up to 15 years per authorities´ guidance.

Who cannot join

  • Active or prior history of central nervous system (CNS) or meningeal involvement of MM.
  • Cardiac atrial or cardiac ventricular MM involvement.
  • Diagnosis of primary amyloidosis (AL), monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia (PCL), active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or Waldenstrom's macroglobulinemia at the time of screening.
  • Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted. Allowed malignancy exceptions are:
  • Localized skin cancer (melanoma and nonmelanoma) that has been completely resected and considered curative within the last 24 months is eligible.
  • Cervix carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible.
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  • Bladder carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible.
  • Breast carcinoma in situ that has been completely resected and considered curative within the last 24 months is eligible. Hormonal therapy after curative-intent treatment is permitted.
  • Prostate cancer that is low grade and localized (Grade Group 1, has not spread to nearby lymph nodes [N0] or metastasized [M0]) within the last 24 months is eligible, including cases under surveillance only as part of standard of care. Androgen deprivation therapy is permitted.
  • Localized renal cell carcinoma (≤ Stage 2) that has been completely resected and considered curative within the last 24 months is eligible.
  • Localized (Stage 1) colorectal cancer that has been completely resected and considered curative (without need for adjuvant chemotherapy) within the last 24 months is eligible.
  • Any prior systemic anti-myeloma treatment (including BCMA-directed treatment) and/or radiotherapy before enrollment. Palliative radiation and corticosteroids (up to cumulative dose of 160mg prednisone or equivalent, and not requiring ongoing therapy) prior to enrollment are permitted. Participants must have recovered from all radiation-related toxicities. Patients with radiation-induced lung injury (RILI, radiation pneumonitis) during screening are excluded.
  • Prior allogeneic stem cell transplant (allo-SCT) (even if for another malignancy)
  • Live vaccine ≤ 4 weeks before enrollment and/or anticipating needing the vaccine during study period.
  • Presence or suspicion of fungal, bacterial, viral, or other infection that is systemic uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if the participant is responding to active treatment and satisfies the criteria of being afebrile (i.e., temperature < 38°C) for at least 24 hours prior to the investigator confirming the participant's eligibility.
  • Acute or chronic active hepatitis A, B, or C infection. Participants with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines or applicable country guidelines.
  • Human immunodeficiency virus (HIV)-seropositive.
  • Participants with history or presence of chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal will not be permitted to receive anti-CD38 monoclonal antibody in combination with VRd therapy; Note: FEV1 testing is required for participants who are planned
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months before enrollment.
  • History or presence of intracranial or CNS disorder, such as hemorrhage, dementia, altered mental status, cerebellar disease, or any autoimmune disease with CNS involvement, PRES, or cerebral edema with confirmed structural defects by appropriate imaging. History of stroke or transient ischemic attack within 12 months before enrollment, or seizure disorders requiring active anticonvulsive medication. Patient with history of neurodegenerative disease (e.g., Parkinson's or Alzheimer's disease) must be excluded.
  • Peripheral neuropathy of Grade 3 or higher (per CTCAE v5.0; participants with Grade 2 peripheral neuropathy are eligible).
  • History of solitary plasmacytoma
  • History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in or requiring systemic immunosuppression or systemic disease-modifying agents within 2 years.
  • History of concomitant genetic syndrome associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome.
  • History of DVT or PE within 6 months before enrollment. Anticoagulants (e.g., warfarin, low-molecular weight heparin, Factor Xa inhibitors) are allowed if DVT/PE occurred > 6 months before enrollment, and if the participant is on a stable maintenance dose.
  • Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J tube, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
  • Major surgery within 28 days before enrollment, or planned surgery required during study participation.
  • Any medical, neurologic or psychiatric condition that in the investigator's opinion is likely to interfere with study procedures including assessment of safety or efficacy of the study treatment.
  • Females who are pregnant or breastfeeding (due to the potentially dangerous effects of the lymphodepleting chemotherapy or induction regimen on the fetus or infant).
  • Participants of both sexes who are not willing to practice highly effective birth control from the time of consent through 12 months following lymphodepleting chemotherapy administration, 12 months after the completion of anitocabtagene autoleucel, 5 months after the last dose of isatuximab, 3 months after the last dose of daratumumab, bortezomib, or 28 days after the last dose of lenalidomide, whichever is longer (refer to Section 12.2). Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential. Participants of both sexes must also comply with any relevant REMS or aRMMs as part of an RMP. Additional information is in Section 6.3.1.
  • As per the investigator's judgment, the participant is unlikely to complete all protocol required study visits or procedures, including follow-up visits, or comply with or tolerate the study requirements for participation (e.g., participants who are at a risk for a thromboembolic event and are not willing to take venous thromboembolism prophylaxis should be excluded).
  • Contraindication to fludarabine or cyclophosphamide.
  • History of allergy or hypersensitivity to any study agent or study drug components. Participants with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carmen López-Carrero contact

0034 699 835 437

carmen@fundacionpethema.es

Roberto Maldonado contact

0034 683 15 66 87

roberto.maldonado@fundacionpethema.es

10 sites in 1 country

Spain10 sites, 10 recruiting

  • Hospital Germans Trias i Pujol (ICO BADALONA)

    Badalona

    Albert Oriol Rocafiguera

    Albert Oriol Rocafiguera

    Recruiting

  • H. Clinic de Barcelona

    Barcelona

    Ana Triguero

    Ana Triguero

    Recruiting

  • H. 12 de Octubre

    Madrid

    Juan Jose Lahuerta, Dr, jjlahuerta@telefonica.net

    Recruiting

  • H. Ramón y Cajal

    Madrid

    J Valentín García Gutiérrez, Dr, jvalentingg@gmail.com

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona

    Paula Rodríguez

    Paula Rodríguez

    Recruiting

  • Hospital Clinico Universitario Salamanca

    Salamanca, 37007

    Mª Victoria Mateos, Dr, mvmateos@usal.es

    Recruiting

  • H. Marqués de Valdecilla

    Santander

    Arancha Bermúdez

    Mercedes Colorado, MD

    Recruiting

  • C H Santiago de Compostela

    Santiago de Compostela

    Natalia Alonso, Dr, natalia.alonso.vence@sergas.es

    Recruiting

  • Complejo Hosp. Regional Virgen del Rocío

    Seville, 41013

    José González Campos, Dr

    Recruiting

  • Hospital Universitario y Politécnico La Fe de Valencia

    Valencia

    Javier de la Rubia Comos

    Javier de la Rubia Comos

    Recruiting

Other trials in Spain

About this study

Official title: A Phase 2, Open-label, Multicenter Multi-cohort Study to Evaluate the Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma

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.

Read the detailed description

Approximately 30 participants will be enrolled to receive induction therapy followed by a single dose of anitocabtagene autoleucel (~ 10 patients treated at target treatment dose per cohort). Participants will be distributed in 3 cohorts of treatment (A, B and C). Participants of cohort A will be transplant eligible while participants of cohorts B and C will not be planned to receive transplantation:

  1. Induction therapy:
  • Cohort A: will consist of a total of 6 cycles D-VRd (28-day cycles); 3 cycles followed by leukapheresis for T-cell collection to manufacture anitocabtagene autoleucel, followed by 3 additional cycles.
  • Cohort B: will consist of a total of 4 cycles Isa-VRd (42-day cycles); 2 cycles followed by leukapheresis for T-cell collection to manufacture anitocabtagene autoleucel, followed by 2 additional cycles.
  • Cohort C: will consist of a total of 4 cycles Isa-VRd (42-day cycles); 2 cycles followed by leukapheresis for T-cell collection to manufacture anitocabtagene autoleucel, followed by 2 additional cycles.
  1. Bridging Therapy: Bridging therapy will not be required because the leukapheresis and manufacturing will be planned during the induction phase to allow the availability of anitocabtagene autoleucel at the end of the induction therapy.
  2. Lymphodepleting Chemotherapy: Chemotherapy regimen consisting of cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day will be administered intravenously (IV) daily for 3 days (Days -5 through -3) before administration of anitocabtagene autoleucel. The fludarabine dose may be adjusted for renal function. Initiation of the 3-day lymphodepleting chemotherapy regimen on Day -7 or Day -6 prior to the anitocabtagene autoleucel infusion on Day +1 is permitted.
  3. Anitocabtagene Autoleucel: Treatment consists of a single infusion of anitocabtagene autoleucel administered intravenous (IV) on Day 1 at a target dose of 115 x 10e6 (± 10 x 10e6) CAR+ viable T cells.
  4. Maintenance Therapy:

Cohorts A and B will receive maintenance therapy which will consist of lenalidomide 10 mg daily (days 1 to 28 of repeated 28-day cycle) for 2 years or until unacceptable toxicity, progression as per IMWG criteria, participant withdrawal of consent, death, or study completion, whichever occurs first. If any of these circumstances occur participant maintenance will end. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

    Daratumumab will be administered by subcutaneous (SC) injection.

  • IsatuximabDrug

    Isatuximab will be administered IV.

  • BortezomibDrug

    Bortezomib dose will be calculated using the patient's actual body surface area at baseline and will be administered by SC injection.

  • LenalidomideDrug

    Lenalidomide will be administered by oral route (all cohorts at induction, and cohorts A and B at maintenance).

  • CyclophosphamideDrug

    As part of lymphodepleting therapy before CAR-T manufacture, administered IV.

  • FludarabineDrug

    As part of lymphodepleting therapy before CAR-T manufacture, administered IV

  • Anitocabtagene AutoleucelDrug

    Single infusion IV

Study groups in NCT07045909
Study groupRoleWhat they receive
Cohort AExperimentalCohort A participants will be transplant eligible. Cohort A participants will receive induction with 6 cycles D-VRd. After induction, lymphodepleting chemotherapy will be administered consisting of cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day intravenous (IV) daily for 3 days before administration of anitocabtagene autoleucel. Initiation of the 3-day lymphodepleting chemotherapy regimen on Day -7 or Day -6 prior to the anitocabtagene autoleucel infusion on Day +1 is permitted. After lymphodepletion, participants will receive a single infusion of anitocabtagene autoleucel administered IV. After CAR T-cell infusion, cohort A participants will receive maintenance therapy with lenalidomide 10 mg daily for 2 years or until unacceptable toxicity, progression as per IMWG criteria, participant withdrawal of consent, death, or study completion, whichever occurs first.
Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Anitocabtagene Autoleucel
Cohort BExperimentalCohort B participants will not be transplant eligible. Cohort B participants will receive induction with 4 cycles Isa-VRd. After induction, lymphodepleting chemotherapy will be administered consisting of cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day IV daily for 3 days before administration of anitocabtagene autoleucel. Initiation of the 3-day lymphodepleting chemotherapy regimen on Day -7 or Day -6 prior to the anitocabtagene autoleucel infusion on Day +1 is permitted. After lymphodepletion, participants will receive a single infusion of anitocabtagene autoleucel administered IV. After CAR T-cell infusion, cohort B participants will receive maintenance therapy with lenalidomide 10 mg daily for 2 years or until unacceptable toxicity, progression as per IMWG criteria, participant withdrawal of consent, death, or study completion, whichever occurs first.
Receives: Drug: Isatuximab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Anitocabtagene Autoleucel
Cohort CExperimentalCohort C participants will not be transplant eligible. Cohort C participants will receive induction with 4 cycles Isa-VRd; 2 cycles followed by leukapheresis for T-cell collection to manufacture anitocabtagene autoleucel, followed by 2 additional cycles. After induction, lymphodepleting chemotherapy will be administered consisting of cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day IV daily for 3 days (Days -5 through -3) before administration of anitocabtagene autoleucel. The fludarabine dose may be adjusted for renal function. Initiation of the 3-day lymphodepleting chemotherapy regimen on Day -7 or Day -6 prior to the anitocabtagene autoleucel infusion on Day +1 is permitted. After lymphodepletion, participants will receive a single infusion of anitocabtagene autoleucel administered IV with a dose of 115 x 10e6 (± 10 x 10e6) CAR+ viable T cells. After CAR T-cell infusion, cohort C participants will not receive maintenance therapy.
Receives: Drug: Isatuximab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Anitocabtagene Autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of all adverse events (AEs)

    To characterize the safety of anitocabtagene autoleucel following induction therapy (incidence of treatment-emergent adverse events).

    Measured: 3 years

  2. Undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10-5) at 12 months (+/- 3 months) after enrollment.

    To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry (NGF, with a sensitivity level of 10-6).

    Measured: 12 months

Secondary outcomes (12)

  1. Undetectable minimal residual disease (MRD) negative CR rate (minimum 10-5) at 2, 6, 12, 18 and 24 months after CAR T infusion and sustained undetectable minimal residual disease (uMRD) annually.

    To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry.

    Measured: 2 years

  2. Stringent complete response (sCR) or complete response (CR) rate, as assessed by investigators according to the International Myeloma Working Group (IMWG) criteria.

    CR measured by cytomorphplogy and flow cytometry.

    Measured: 6 months

  3. Overall MRD negativity (minimum 10e-5)

    MRD measured by Next Generation Flow Cytometry.

    Measured: 3 years

  4. Rate of conversion from undetectable to detectable MRD as well as biochemical progression rate.

    MRD measured by Next Generation Flow Cytometry. Biochemical progression by measuring serum and/or urine monoclonal protein alone or with clinical features suggestive of progression including CRAB (C, hypercalcemia; R, renal failure; A, anemia; B, bone disease) symptoms.

    Measured: 3 years

  5. Time to biochemical progression (including the conversion from undetectable to detectable MRD).

    MRD measured by Next Generation Flow Cytometry. Serum and/or urine monoclonal protein alone or with clinical features suggestive of progression including CRAB (C, hypercalcemia; R, renal failure; A, anemia; B, bone disease) symptoms.

    Measured: 3 years

  6. Undetectable MRD at 10e-6 (0.0001%)

    MRD measured by Next Generation Flow Cytometry. Undetectable MRD at 10e-6 (10 elevated to -6, which is the same as 0.0001%) means no presence of multiple myloma cells within 1,000,000 cells analyzed by flow cytometry

    Measured: 3 years

  7. Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) criteria

    ORR is defined as the proportion of participants who achieve a best overall response of at least partial response (PR) or better (sCR, CR, VGPR, or PR) per IMWG criteria.

    Measured: 3 years

  8. Duration of Response (DoR)

    DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per IMWG criteria and is defined as the time from first overall response to disease progression per IMWG criteria, or death from any cause, whichever occurs first.

    Measured: 3 years

  9. Progression Free Survival (PFS)

    PFS is defined as the time from enrollment to the first documented disease progression per IMWG criteria as determined by investigator assessed or death due to any cause, whichever occurs first.

    Measured: 3 years

  10. Overall survival (OS)

    OS is defined as the time from enrollment to the date of death from any cause.

    Measured: 3 years

  11. Overall rate of "imaging plus MRD negative" (using PET/CT per International Myeloma Working Group [IMWG] criteria)

    Measured by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan using the Deauville score.

    The Deauville score is a 5-point grading system used on FDG PET/CT imaging to assess treatment response. It is based on comparing FDG uptake in lesions with uptake in the liver and mediastinum. The Deauville score values are:

    1. No FDG uptake above background.
    2. Uptake less than the liver.
    3. Uptake equal to the liver.
    4. Uptake moderately greater than the liver.
    5. Uptake markedly greater than the liver, typically 2-3 times greater.

    Measured: 3 years

  12. Expansion and persistence of anitocabtagene autoleucel in peripheral blood

    Measured by Next Generation Flow Cytometry.

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start30 Jun 2025
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Phase 2, open-label, multicenter multicohort trial
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07045909
Sponsor's protocol ID
GEM-AnitoFIRST
Acronym
GEM-AnitoFIRST
Status last verified
Jul 2025
First submitted
22 Jun 2025
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab, Isatuximab and Bortezomib in people with De Novo Multiple Myeloma and Anitocabtagene Autoleucel, run by PETHEMA Foundation at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carmen López-Carrero (0034 699 835 437, carmen@fundacionpethema.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of all adverse events (AEs) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07045909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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