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New treatment option for Multiple Myeloma
Official title The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma
ClinicalTrials.gov ID: NCT05841550
What this study is testing
What is TG01?
TG01 is an investigational medicine, 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
- The goal of this clinical trial is to test the safety, tolerability, and efficacy of TG01 vaccination in patients with KRAS or NRAS mutation on codon 12/13 mutation who has multiple myeloma or high-risk smoldering multiple myeloma. The main question it aims to answer are: Is TG01/QS-21 vaccination safe and tolerable for this patient group?
- 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
- Male or female patients ≥ 18 years of age
- RAS mutation (KRAS/NRAS codon 12/13 mutation) detected on archival or fresh bone marrow material with VariantPlex Myeloid Panel
- Confirmed diagnosis of high-risk smoldering multiple myeloma (SMM) according to IMWG criteria (30) and high-risk criteria as listed up below OR...
- In patients with high-risk SMM at least 2 of 3 following abnormalities, based on laboratory data obtained at screening must be fulfilled:
- Serum M-protein \>20 g/L.
You likely can't join if
- Pregnant or lactating women or women without a pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to...
- Medical conditions such as but not limited to:
- Any uncontrolled infection
- Uncontrolled cardiac failure classification III or IV (NYHA)
- Uncontrolled systemic and gastro-intestinal inflammatory conditions
- History of adverse reactions to vaccines
See the full eligibility criteria
- Male or female patients ≥ 18 years of age
- RAS mutation (KRAS/NRAS codon 12/13 mutation) detected on archival or fresh bone marrow material with VariantPlex Myeloid Panel
- Confirmed diagnosis of high-risk smoldering multiple myeloma (SMM) according to IMWG criteria (30) and high-risk criteria as listed up below OR confirmed diagnosis of multiple myeloma (MM) according to IMWG criteria and...
- In patients with high-risk SMM at least 2 of 3 following abnormalities, based on laboratory data obtained at screening must be fulfilled:
- Serum M-protein \>20 g/L.
- Serum involved/uninvolved FLC ratio \>20.
- BMPC \>20%. OR presence of ≥10% BMPC and at least one of the following based on laboratory data obtained at screening:
- Serum M-protein ≥30 g/L (If IgA, IgA ≥20g/L)
- Serum involved/uninvolved FLC ratio ≥8 (but \<100)
- Abnormal PC immunophenotype (≥95% of BMPCs are clonal) and reduction of ≥1uninvolved Ig isotype (Only IgG, IgA and IgM will be considered)
- Progressive increase in Serum M-protein level (evolving type of SMM) defined as an increase of Serum M-protein ≥10% in the last 12 months before enrolment in the study. This increase must be consistent from one to...
- Both high-risk SMM and MM patients must have evidence of measurable disease in accordance with IMWG criteria
- If patient with MM was eligible for ASCT, ASCT must have been performed, and patients cannot be enrolled until 3 months after ASCT
- Patient should not be expected to require immediate, subsequent line of treatment for at least 2 months
- Patient has not had reduction of clonal plasma cell markers for last two cycles (last two months if off treatment). If a patient had no reduction during the last two cycles of induction before ASCT, the patient can be...
- Following ASCT, the patient cannot be enrolled without having tried lenalidomide maintenance given at standard doses for at least two cycles, if the clonal markers had a reduction during the last 2 cycles of induction...
- ECOG performance status 0-1
- Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test at Screening and agree to use a highly effective method of contraception during treatment and for 3 months following last dose of...
- Male patients must use an effective barrier method of contraception during treatment and for 3 months following the last dose if sexually active with a FCBP.
- Ability to provide written informed consent and can understand and comply with the requirements of the study
- Pregnant or lactating women or women without a pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
- Medical conditions such as but not limited to:
- Any uncontrolled infection
- Uncontrolled cardiac failure classification III or IV (NYHA)
- Uncontrolled systemic and gastro-intestinal inflammatory conditions
- History of adverse reactions to vaccines
- Active malignancy with worse prognosis than multiple myeloma
- Likely to require treatment intervention for multiple myeloma within two months of start of treatment with TG01/QS-21
- Known history of positive tests for HIV/AIDS, hepatitis B or C
- Planned to receive yellow fever or other live (attenuated) vaccines during the course of study
- Known hypersensitivity to QS-21.
- Only participants who are able to consent will be included in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Oslo, Norway
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 Oslo, Oslo, Norway. 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.