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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05841550
Study type Interventional
Source Oslo University Hospital
Contact Hanne Norseth, MD
Phone 92847595
Email h.m.norseth@gmail.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 19, 2023
Completion date May 19, 2035

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