Multiple MyelomaPhase 1/2NCT05841550
The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma
A Phase 1/2 study testing TG01 in people with Multiple Myeloma and Smoldering Multiple Myeloma, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Smoldering Multiple Myeloma
- What is being tested?
- TG01
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 19 May 2023to 19 May 2035
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ≥
- 1 line of treatment
- In patients with high-risk SMM at least 2 of 3 following abnormalities, based on laboratory data obtained at screening must be fulfilled:
- Serum M-protein >20 g/L.
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- Serum involved/uninvolved FLC ratio >20.
- BMPC >20%. OR presence of ≥10% BMPC and at least one of the following based on laboratory data obtained at screening:
- Serum M-protein ≥30 g/L (If IgA, IgA ≥20g/L)
- Serum involved/uninvolved FLC ratio ≥8 (but <100)
- Abnormal PC immunophenotype (≥95% of BMPCs are clonal) and reduction of ≥1uninvolved Ig isotype (Only IgG, IgA and IgM will be considered)
- Progressive increase in Serum M-protein level (evolving type of SMM) defined as an increase of Serum M-protein ≥10% in the last 12 months before enrolment in the study. This increase must be consistent from one to another sample (i.e., no decrease observed between 2 increased Serum M-protein values)
- Both high-risk SMM and MM patients must have evidence of measurable disease in accordance with IMWG criteria
- If patient with MM was eligible for ASCT, ASCT must have been performed, and patients cannot be enrolled until 3 months after ASCT
- Patient should not be expected to require immediate, subsequent line of treatment for at least 2 months
- Patient has not had reduction of clonal plasma cell markers for last two cycles (last two months if off treatment). If a patient had no reduction during the last two cycles of induction before ASCT, the patient can be enrolled, provided 3 months after ASCT
- 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
- ECOG performance status 0-1
- Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test at Screening and agree to use a highly effective method of contraception during treatment and for 3 months following last dose of drug.
- Male patients must use an effective barrier method of contraception during treatment and for 3 months following the last dose if sexually active with a FCBP.
- Ability to provide written informed consent and can understand and comply with the requirements of the study
Who cannot join
- 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)
- Medical conditions such as but not limited to:
- Any uncontrolled infection
- Uncontrolled cardiac failure classification III or IV (NYHA)
- Uncontrolled systemic and gastro-intestinal inflammatory conditions
- History of adverse reactions to vaccines
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- Active malignancy with worse prognosis than multiple myeloma
- Likely to require treatment intervention for multiple myeloma within two months of start of treatment with TG01/QS-21
- Known history of positive tests for HIV/AIDS, hepatitis B or C
- Planned to receive yellow fever or other live (attenuated) vaccines during the course of study
- Known hypersensitivity to QS-21.
- Only participants who are able to consent will be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo Myeloma Center
Oslo, Oslo, 0450
Fredrik B Schjesvold, MD, PhD, 996 97 796 ext. 0047, fredrikschjesvold@gmail.com
Hanne M Norseth, MD, 92847595 ext. 0047, h.m.norseth@gmail.com
About this study
Official title: A Phase 1/Phase 2 Study to Investigate Safety, Tolerability and Efficacy With TG01/QS-21 Vaccine Administration in Patients With Confirmed KRAS or NRAS Codon 12/13 Mutation and High-risk Smoldering Multiple Myeloma or Multiple Myeloma and Evidence of Measurable Disease ≥ 1 Line of Treatment
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
- Multiple Myeloma, Smoldering Multiple Myeloma
- Being tested
- TG01
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG01Biological
All participants will receive the same treatment as described under arm
| Study group | Role | What they receive |
|---|---|---|
| TG01 | Experimental | TG01 is a sterile lyophilizate consisting of a mixture of seven peptides. The finished product is a white powder for injection, consisting only of the active substances containing 2.1 mg of peptides (individual peptides comprising 0.3 mg each). The lyophilizate is to be reconstituted with QS-21 for injection before use.
QS-21 is a naturally occurring saponin molecule purified from the South American tree Quillaja saponaria Molina. QS-21 Solution is supplied in a 2 mL CZ resin vial as a sterile, solution in PBS (phosphate buffered saline) at a concentration of 0.5 mg/mL QS-21 (500 mcg/mL) with each vial containing 0.7 mL intended single use only.
The vaccine will be given subcutaneously Treatment consists of 12 doses TG01/QS-21 vaccine given every 2 weeks in the first 12 weeks, followed by every 8 weeks until week 52.
TG01 dose 0.7 mg dose and QS-21 50 ug. Receives: Biological: TG01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline until 30 days after last dose of study drug, up to approximately 3 years
Percentage of participants discontinuing treatment secondary to treatment-related adverse events
Percentage of participants discontinuing treatment secondary to treatment-related adverse events
Measured: Up to approximately 3 years
Secondary outcomes (5)
Number of patients with Progression Free Survival (PFS)
defined as the time from study treatment start to disease progression for every patient
Measured: Baseline to 11 years
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)
Measured: Baseline until end of study, assessed up to 11 years
Overall response rate per patient
The proportion of patients who achieve partial response (PR) or better following at least one dose of study treatment
Measured: Baseline to approximately 3 years
Overall Survival (OS) per patient
The OS rate of patients receiving 1 or more study treatments
Measured: Baseline until the end of study, assessed up to 11 years
Time to next treatment (TTNT) per patient
defined as the time between the start date of the current treatment line and the start date of the next treatment line
Measured: Baseline until the end of study, assessed up to 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start19 May 2023
- Primary completion19 May 2027 (estimated)
- Study completion19 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Targovax ASA
- Responsible party
- Principal investigator, Fredrik Hellem Schjesvold, Oslo University Hospital
- Investigators
- Fredik Schjesvold, MD PhD, Principal investigator, Oslo Myeloma Center, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841550
- Sponsor's protocol ID
- OMC04
- Status last verified
- Jul 2025
- First submitted
- 13 Mar 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, Informed consent form, Clinical trial results, Investigator Brochure, IMPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/Phase 2 Study to Investigate Safety, Tolerability and Efficacy With TG01/QS-21 Vaccine Administration in Patients With Confirmed KRAS or NRAS Codon 12/13 Mutation and High-risk Smoldering Multiple Myeloma or Multiple Myeloma and Evidence of Measurable Disease ≥ 1 Line of Treatment
- ClinicalTrials.gov ID
- NCT05841550
- Acronym / sponsor ID
- OMC04
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Targovax ASA
- Study start
- 19 May 2023 (actual)
- Primary completion
- 19 May 2027 (estimated)
- Study completion
- 19 May 2035 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TG01 | Experimental | Biological: TG01TG01 is a sterile lyophilizate consisting of a mixture of seven peptides. The finished product is a white powder for injection, consisting only of the active substances containing 2.1 mg of peptides (individual peptides comprising 0.3 mg each). The lyophilizate is to be reconstituted with QS-21 for injection before use. QS-21 is a naturally occurring saponin molecule purified from the South American tree Quillaja saponaria Molina. QS-21 Solution is supplied in a 2 mL CZ resin vial as a sterile, solution in PBS (phosphate buffered saline) at a concentration of 0.5 mg/mL QS-21 (500 mcg/mL) with each vial containing 0.7 mL intended single use only. The vaccine will be given subcutaneously Treatment consists of 12 doses TG01/QS-21 vaccine given every 2 weeks in the first 12 weeks, followed by every 8 weeks until week 52. TG01 dose 0.7 mg dose and QS-21 50 ug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 ≥
- 1 line of treatment
- In patients with high-risk SMM at least 2 of 3 following abnormalities, based on laboratory data obtained at screening must be fulfilled:
Key exclusion criteria (12 listed)
- 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)
- Medical conditions such as but not limited to:
- Active malignancy with worse prognosis than multiple myeloma
- Likely to require treatment intervention for multiple myeloma within two months of start of treatment with TG01/QS-21
- Known history of positive tests for HIV/AIDS, hepatitis B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG01All participants will receive the same treatment as described under arm | Biological | TG01 |
Primary outcome
Percentage of participants with adverse events (AEs)
Time frame: Baseline until 30 days after last dose of study drug, up to approximately 3 years
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.
Percentage of participants discontinuing treatment secondary to treatment-related adverse events
Time frame: Up to approximately 3 years
Percentage of participants discontinuing treatment secondary to treatment-related adverse events
5 secondary outcomes
Number of patients with Progression Free Survival (PFS)
Time frame: Baseline to 11 years
Concentration of TG01-specific T-cell specific cytokine production
Time frame: Baseline until end of study, assessed up to 11 years
Overall response rate per patient
Time frame: Baseline to approximately 3 years
Overall Survival (OS) per patient
Time frame: Baseline until the end of study, assessed up to 11 years
Time to next treatment (TTNT) per patient
Time frame: Baseline until the end of study, assessed up to 11 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Yes. Study protocol, Informed consent form, Clinical trial results, Investigator Brochure, IMPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fredik Schjesvold, MD PhD principal investigator
Oslo Myeloma Center, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TG01 in people with Multiple Myeloma and Smoldering Multiple Myeloma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanne Norseth, MD (92847595 ext. 0047, h.m.norseth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with adverse events (AEs) (time frame: Baseline until 30 days after last dose of study drug, up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.