The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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 ≥
Serum M-protein >20 g/L.
Disqualifiers
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)
Any uncontrolled infection
Uncontrolled cardiac failure classification III or IV (NYHA)
Uncontrolled systemic and gastro-intestinal inflammatory conditions
Trial design
Design model
Single group
Treatments tested in this trial
TG01
Biological/VaccineAll participants will receive the same treatment as described under arm
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TG01Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants with adverse events (AEs)
An Adverse Event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame
Baseline until 30 days after last dose of study drug, up to approximately 3 years2
Percentage of participants discontinuing treatment secondary to treatment-related adverse events
Percentage of participants discontinuing treatment secondary to treatment-related adverse events
Time frame
Up to approximately 3 yearsSecondary outcomes
1
Number of patients with Progression Free Survival (PFS)
defined as the time from study treatment start to disease progression for every patient
Time frame
Baseline to 11 years2
Concentration of TG01-specific T-cell specific cytokine production
The immune response to TG01 will be measured by IFNg/TNFa ELISPOT or FluoroSpot quantifying the TG01 T-cell specific cytokine production. A positive immune response will be defined as a 2-fold higher mean spot number in experimental wells (with vaccine peptides) compared to control wells (medium)
Time frame
Baseline until end of study, assessed up to 11 years3
Overall response rate per patient
The proportion of patients who achieve partial response (PR) or better following at least one dose of study treatment
Time frame
Baseline to approximately 3 years4
Overall Survival (OS) per patient
The OS rate of patients receiving 1 or more study treatments
Time frame
Baseline until the end of study, assessed up to 11 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
Targovax ASA
Collaborator
Source ClinicalTrials.gov