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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05841550 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received autologous stem cell transplant and immunomodulatory agent.
Does this trial require KRAS?
Yes, KRAS codon 12/13 mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS codon 12/13 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages