NCT05841550 The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma
| NCT ID | NCT05841550 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Oslo University Hospital |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2027-05-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-05-19 with a primary completion date of 2027-05-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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? Is TG01/QS-21 vaccination treatment efficient in this group in terms of increased overall response rate, overall survival rate, progression-free survival, and time til next treatment? Is there an immunological response to the vaccine? Participants will be given TG01/QS-21 vaccination treatment. Treatment consists of 12 doses of TG01/QS-21 vaccine given every two weeks in the first 12 weeks, followed by every eight weeks until week 52.
Eligibility Criteria
Inclusion 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 measurable disease following ≥ 1 line of treatment * In patients with high-risk SMM at least 2 of 3 following abnormalities, based on laboratory data obtained at screening must be fulfilled: 1. Serum M-protein \>20 g/L. 2. Serum involved/uninvolved FLC ratio \>20. 3. 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 another sample (i.e., no decrease observed between 2 increased Serum M-protein values) * 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 enrolled, provided 3 months after ASCT * 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 treatment. Lenalidomide will be stopped when entering the study * 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 drug. * 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 Exclusion Criteria: * 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: 1. Any uncontrolled infection 2. Uncontrolled cardiac failure classification III or IV (NYHA) 3. Uncontrolled systemic and gastro-intestinal inflammatory conditions 4. 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.
Contact & Investigator
Fredik Schjesvold, MD PhD
PRINCIPAL INVESTIGATOR
Oslo Myeloma Center, Oslo University Hospital
Frequently Asked Questions
Who can join the NCT05841550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05841550 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05841550 currently recruiting?
Yes, NCT05841550 is actively recruiting participants. Contact the research team at h.m.norseth@gmail.com for enrollment information.
Where is the NCT05841550 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05841550 clinical trial?
NCT05841550 is sponsored by Oslo University Hospital. The principal investigator is Fredik Schjesvold, MD PhD at Oslo Myeloma Center, Oslo University Hospital. The trial plans to enroll 20 participants.