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New treatment option for High Risk Smoldering Multiple Myeloma
Official title Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma
ClinicalTrials.gov ID: NCT06574126
What this study is testing
What is Group 1: Dara-VRD followed by apheresis and cilta-cel infusion?
Group 1: Dara-VRD followed by apheresis and cilta-cel infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high risk smoldering multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent. \-...
- Serum M-protein ≥2 gm/dL
- Involved to uninvolved FLC ratio ≥20
- BMPC % ≥20% to \<40% OR ii) Presence of ≥95% of BMPC with an aberrant phenotype within the BMPC compartment and immunoparesis present defined as a...
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 1...
You likely can't join if
- \- History of uncontrolled illness, including but not limited to MGUS, standard risk smoldering myeloma, active myeloma by current IMWG definition...
- Noninvasive cervical cancer treated within the last 24 months that is considered completely cured.
- Localized prostate cancer (N0M0): i) with a Gleason score ≤6, treated within the last 24 months or untreated and under surveillance. ii) with a...
- If any of the following exist at screening, participant will be excluded because this trial involves an investigational agent whose genotoxic...
- Other comorbidity which would interfere with subject's ability to participate in trial, eg, uncontrolled infection, uncompensated heart, or lung...
- Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to...
See the full eligibility criteria
- \- Be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent. \- High-risk SMM defined as having 1 of the following 2 criteria: i) High-risk...
- Serum M-protein ≥2 gm/dL
- Involved to uninvolved FLC ratio ≥20
- BMPC % ≥20% to \<40% OR ii) Presence of ≥95% of BMPC with an aberrant phenotype within the BMPC compartment and immunoparesis present defined as a reduction of at least 25% below the lower normal limit for ≥1 uninvolved...
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 1 year after receiving the cilta-cel infusion. If the male...
- A male participant must agree not to donate sperm for the purposes of reproduction during the study and for 1 year after receiving the last dose of study treatment. Male participants should consider preservation of...
- A male participant must agree not to plan to father a child while enrolled in this study or within 1 year after the last dose of study treatment.
- Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- An additional ICF will be collected to get participants authorization to collect the necessary samples for performing the Biological studies indicated in this protocol.
- Be willing and able to adhere to the lifestyle restrictions specified in this protocol.
- \- History of uncontrolled illness, including but not limited to MGUS, standard risk smoldering myeloma, active myeloma by current IMWG definition, light chain amyloidosis with organ involvement or patients with...
- Noninvasive cervical cancer treated within the last 24 months that is considered completely cured.
- Localized prostate cancer (N0M0): i) with a Gleason score ≤6, treated within the last 24 months or untreated and under surveillance. ii) with a Gleason score of 3+4 that has been treated more than 6 months prior to full...
- If any of the following exist at screening, participant will be excluded because this trial involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are...
- Other comorbidity which would interfere with subject's ability to participate in trial, eg, uncontrolled infection, uncompensated heart, or lung disease.
- Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- History of neurodegenerative disease (eg, Parkinson or stroke within 6 months).
- Medical history of treatment for another malignancy \<2 years before trial enrollment, other concurrent chemotherapy, or any ancillary therapy considered investigational. Note: Bisphosphonates are considered supportive...
- Known seropositive for or active viral infection with HIV, HBV, hepatitis C virus (HCV), or SARS-CoV-2 (Coronavirus Disease 2019 [COVID-19]). i) Participants who are positive for SARS-COV-2 antibody, HIV1 and 2...
The study team makes the final eligibility decision.
Where it's taking place
- Salamanca, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salamanca, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.