OncoMatch/Clinical Trials/NCT05841550
The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma
Is NCT05841550 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies TG01 for multiple myeloma.
Treatment: TG01 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: KRAS codon 12/13 mutation
Required: NRAS codon 12/13 mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: autologous stem cell transplant — if eligible for ASCT, must have been performed
If patient with MM was eligible for ASCT, ASCT must have been performed, and patients cannot be enrolled until 3 months after ASCT
Must have received: immunomodulatory agent (lenalidomide) — maintenance after ASCT if clonal markers had a reduction during last 2 cycles of induction
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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