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New treatment option for Multiple Myeloma
Official title Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
ClinicalTrials.gov ID: NCT02291848
What this study is testing
What is TAA-specific CTLs?
TAA-specific CTLs is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for 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 study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma.
- Phase 1: an early, usually small safety study
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
- Procurement Any patient, at least 18 yrs old regardless of sex, with a diagnosis of high risk MGUS/smoldering myeloma or patients with a diagnosis of...
- Any patient, ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS (defined as have 2 of the following: 1. Non IgG MGUS, 2. M protein ≥...
- Patients with life expectancy greater than or equal to 6 weeks.
- Hgb greater than or equal to 7.0 (transfusions allowed).
- Patient able to give informed consent. Treatment \- Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving...
You likely can't join if
- Patients with severe active infection.
- Patients with active HIV infection at time of procurement (can be pending at the time of blood draw). Treatment Exclusion Criteria
- Patients with severe active infection.
- Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
- Pregnant or breastfeeding
See the full eligibility criteria
- Procurement Any patient, at least 18 yrs old regardless of sex, with a diagnosis of high risk MGUS/smoldering myeloma or patients with a diagnosis of Multiple myeloma after receiving at least one treatment regimen OR
- Any patient, ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS (defined as have 2 of the following: 1. Non IgG MGUS, 2. M protein ≥ 1.5 g/dl, 3. Abnormal free light chain ratio (\ 1.65 for kappa...
- Patients with life expectancy greater than or equal to 6 weeks.
- Hgb greater than or equal to 7.0 (transfusions allowed).
- Patient able to give informed consent. Treatment \- Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least one treatment regimen. If patient has received an autologous...
- Patients with life expectancy greater than or equal to 6 weeks.
- Pulse oximetry of \>93% on room air in patients who previously received radiation therapy.
- Patients with a Karnofsky score of greater than or equal to 50.
- Patients with bilirubin less than or equal to 2 times upper limit of normal, AST less than or equal to 3 times upper limit of normal, and Hgb greater than or equal to 7.0 (transfusion allowed).
- Engrafted post transplant (ANC \>500) and ANC \>500 at the time of infusion if applicable.
- Patients with a creatinine less than or equal to 2x upper limit of normal for age.
- Patients should have been off other investigational therapy for one month prior to entry in this study.
- Patients should have been off conventional therapy for at least 48 hours prior to entry in this study (except for lenalidomide, thalidomide, pomalidomide or immune checkpoint inhibitors such as CTLA4 and/or PD-1/PD-L1...
- Patient able to give informed consent.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more...
- Patients with severe active infection.
- Patients with active HIV infection at time of procurement (can be pending at the time of blood draw). Treatment Exclusion Criteria
- Patients with severe active infection.
- Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
- Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Houston, Texas, United States. 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.