Actively Recruiting
The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma
Led by Oslo University Hospital · Updated on 2025-08-05
20
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
T
Targovax ASA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older
- Confirmed KRAS or NRAS codon 12/13 mutation detected on bone marrow material
- Confirmed diagnosis of high-risk smoldering multiple myeloma according to IMWG criteria with specific laboratory abnormalities OR confirmed multiple myeloma with measurable disease after at least one line of treatment
- For high-risk smoldering multiple myeloma, at least two of the following: Serum M-protein >20 g/L, serum involved/uninvolved FLC ratio >20, bone marrow plasma cells >20%; OR presence of ≥10% bone marrow plasma cells and additional specified laboratory criteria
- Evidence of measurable disease per IMWG criteria
- If eligible for autologous stem cell transplant (ASCT), it must have been performed and enrollment delayed at least 3 months after ASCT
- No immediate need for subsequent treatment for at least 2 months
- No reduction of clonal plasma cell markers in last two cycles (or last two months if off treatment)
- Lenalidomide maintenance must have been tried after ASCT if clonal markers reduced during induction; stopped before study entry
- ECOG performance status 0-1
- Female patients of child-bearing potential must have negative pregnancy test and agree to use effective contraception during treatment and 3 months after
- Male patients must use effective contraception if sexually active with female patients of child-bearing potential during treatment and 3 months after
- Ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Pregnant or lactating women or women without pregnancy test at baseline (postmenopausal women must be amenorrhoeic for at least 12 months)
- Uncontrolled infections
- Uncontrolled cardiac failure NYHA classification III or IV
- Uncontrolled systemic or gastrointestinal inflammatory conditions
- History of adverse reactions to vaccines
- Active malignancy with worse prognosis than multiple myeloma
- Expected treatment for multiple myeloma within two months of study start
- Known positive HIV/AIDS, hepatitis B or C
- Planned to receive yellow fever or other live vaccines during study
- Known hypersensitivity to QS-21
- Participants unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo Myeloma Center
Oslo, Oslo, Norway, 0450
Actively Recruiting
Research Team
H
Hanne Norseth, MD
CONTACT
H
Hedda B Monsen
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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