Vaccination with TG01/QS-21 for patients with high-risk smoldering multiple myeloma and multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety, tolerability, and efficacy of the TG01/QS-21 vaccine in patients with high-risk smoldering multiple myeloma or multiple myeloma who have specific KRAS or NRAS mutations. Participants will receive 12 doses of the vaccine over 52 weeks, with doses administered every two weeks initially, followed by every eight weeks. The study will assess various outcomes, including overall response rate, overall survival, progression-free survival, and immunological response to the vaccine. The trial is designed to provide insights into the potential benefits of this vaccination approach for these patient populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. Serum M-protein \>20 g/L.
  2. Serum involved/uninvolved FLC ratio \>20.
  3. 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

Exclusion Criteria:

* 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:

  1. Any uncontrolled infection
  2. Uncontrolled cardiac failure classification III or IV (NYHA)
  3. Uncontrolled systemic and gastro-intestinal inflammatory conditions
  4. History of adverse reactions to vaccines
* 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.

Where it's running

• Oslo Myeloma Center
  Oslo, Oslo, Norway Recruiting

Study contacts

• Principal investigator: Fredik Schjesvold, MD PhD — Oslo Myeloma Center, Oslo University Hospital
• Study coordinator: Hanne Norseth, MD
• Email: h.m.norseth@gmail.com
• Phone: 92847595

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prolonged overnight fasting combined with a Mediterranean-style diet for people with multiple myeloma or precursor conditions

  This program will test whether longer overnight fasting paired with a Mediterranean-style eating plan is doable for adults with MGUS, smoldering myeloma, or newly diagnosed multiple myeloma who are starting treatment.

  Recruiting University of Miami · Miami, Florida · NCT07446777

• Using Whole Body MRI to Improve Cancer Detection

  This study is testing if Whole Body MRI can help find bone and soft tissue problems in people with different types of cancer, like lymphoma and advanced prostate and breast cancer.

  Recruiting at 2 sites Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Bologna, BO and 2 other locations · NCT06895291

• Combining JNJ-79635322 with Daratumumab or Pomalidomide for Multiple Myeloma Treatment

  This study is testing a new drug called JNJ-79635322 combined with either daratumumab or pomalidomide to see how safe and effective it is for people with multiple myeloma.

  Recruiting at 16 sites Phase 1 Janssen Research & Development, LLC · Denver, Colorado and 15 other locations · NCT06768489

• Collection and analysis of biological samples from patients with multiple myeloma and related conditions

  This study is collecting and storing blood samples from patients with multiple myeloma and similar conditions to help researchers learn more about these diseases and improve treatments.

  Recruiting at 41 sites European Myeloma Network B.V. · Melbourne and 40 other locations · NCT06237803

• Testing Teclistamab for high-risk smoldering multiple myeloma

  This study is testing if Teclistamab can work better than a mix of Lenalidomide and Dexamethasone for people with high-risk smoldering multiple myeloma.

  Recruiting at 3 sites Phase 2 Dana-Farber Cancer Institute · Denver, Colorado and 2 other locations · NCT05469893

• Understanding different types of multiple myeloma precursor conditions

  This study is trying to tell the difference between two early stages of multiple myeloma, smoldering multiple myeloma and monoclonal gammopathy of undetermined significance, to better understand how they progress or stay stable.

  Recruiting University of Miami · Miami, Florida · NCT05361694

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.