Actively Recruiting
Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma
Led by PETHEMA Foundation · Updated on 2024-10-26
20
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single arm, multicenter, interventional study with Dara-VRD followed by cilta-cel in high-risk smoldering multiple myeloma (SMM) patients. The primary objectives of this trial, related with efficafy and safety of the treatment, are i) to evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease (MRD) at 6 months, 12 months, and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat (ITT) population; ii) to annotate frequency and severity of adverse events (AE) and serious adverse events (SAE), as well as data from laboratory tests aslo related with safety such as Immunoglobulin (Ig) G levels, complete blood count (CBC) cytopenia adn T-cell populations. Secondary objectives are related with response to therapy and will measure different categories of response and survival.
CONDITIONS
Official Title
Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older (or legal age of consent) at the time of informed consent.
- Have high-risk smoldering multiple myeloma defined by either: i) Meeting at least two criteria of the Mayo 20-2-20 standard (serum M-protein 62 gm/dL, involved to uninvolved free light chain ratio 620, bone marrow plasma cells 20% to <40%) or ii) Having 6595% bone marrow plasma cells with aberrant phenotype and immunoparesis.
- Have an ECOG Performance Status of 1 or less.
- Have an estimated glomerular filtration rate (eGFR) of 40 mL/min or higher.
- Have laboratory values within 21 days prior to screening: total bilirubin 62.0 mg/dL, AST 63 times upper limit of normal, ALT 63 times upper limit of normal.
- Have hemoglobin 658.0 g/dL without red blood cell transfusion in the 7 days before testing (recombinant erythropoietin use allowed).
- Have neutrophils 651.0 x 10^9/L without growth factor support in the 7 days before testing.
- Have platelets 6575 x 10^9/L without transfusion support in the 7 days before testing.
- Have lymphocyte count 650.3 x 10^9/L.
- Be seronegative for HIV or have controlled HIV if seropositive.
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to ongoing testing and use effective contraception during and for 6 months after treatment.
- Female participants not of childbearing potential or practicing at least one highly effective contraceptive method.
- Female participants using oral contraceptives must also use a barrier method.
- Female participants must agree not to donate eggs during and for 6 months after treatment.
- Male participants must use condoms during the study and for 1 year after treatment, agree not to donate sperm, and not plan to father a child during this period.
- Must sign informed consent forms and agree to study procedures and lifestyle restrictions.
You will not qualify if you...
- History of uncontrolled illness including MGUS, standard risk smoldering myeloma, active myeloma, light chain amyloidosis with organ involvement, or extramedullary disease.
- Non-muscle-invasive bladder cancer treated within the last 24 months.
- Skin cancer (melanoma or nonmelanoma) treated within the last 24 months.
- Noninvasive cervical cancer treated within the last 24 months.
- Localized prostate cancer with specific criteria depending on Gleason score and treatment status.
- Adequately treated lobular or ductal carcinoma in situ.
- History of localized breast cancer under antihormonal treatment with very low risk of recurrence.
- Known allergies or intolerance to cilta-cel or its ingredients.
- Major surgery or significant injury within 14 days before treatment start.
- Pregnancy, nursing, or unwillingness to use effective contraception.
- Comorbidities interfering with participation, such as uncontrolled infection or heart/lung disease.
- Medical or psychiatric illness interfering with treatment completion.
- History of neurodegenerative disease or stroke within 6 months.
- Recent treatment for another malignancy within 2 years, concurrent chemotherapy, or investigational therapy.
- Active or uncontrolled infections including HIV, hepatitis B or C, or COVID-19.
- Any condition deemed by the investigator to compromise well-being or study assessments.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clinico Universitario Salamanca
Salamanca, Spain, 37007
Actively Recruiting
Research Team
M
María-Victoria Mateos
CONTACT
J
Jesús San Miguel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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