Using blood tests to improve treatment for newly diagnosed multiple myeloma patients
Phase 2 Study Applying Innovative Minimal Residual Disease (MRD) Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by Autologous Stem Cell Transplantation (ASCT) - TAURUS
This study is testing if a blood test can give better information about treatment response for people with newly diagnosed multiple myeloma who are about to receive high-dose therapy and stem cell transplants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | European Myeloma Network B.V. Research network |
| Drugs / interventions | daratumumab, Radiation |
| Locations | 31 sites (Innsbruck and 30 other locations) |
| Trial ID | NCT06189833 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study focuses on patients with newly diagnosed multiple myeloma who are treatment-naïve and are scheduled to undergo high-dose therapy followed by autologous stem cell transplantation. The study evaluates the effectiveness of a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using blood samples, comparing it to traditional minimal residual disease (MRD) assessments that utilize bone marrow samples. The goal is to determine if the blood test can provide better insights into disease status and treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed, measurable multiple myeloma who are treatment-naïve and plan to undergo high-dose therapy and autologous stem cell transplantation.
Not a fit: Patients with relapsed multiple myeloma or those who have previously received treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective monitoring of treatment response in multiple myeloma patients, potentially improving outcomes.
How similar studies have performed: Other studies have shown promise in using blood-based MRD techniques, but this specific approach using MS-MRD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 70 years of age, inclusive. * Must have a new diagnosis of MM as per IMWG criteria. * Measurable disease * Newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. * Clinical laboratory values meeting the required criteria during screening and ≤3 days prior to receiving first study treatment dose. * Adequate bone marrow function. * Adequate liver function. * Adequate renal function. * A female of childbearing potential (FOCBP) must have two negative serum or urine pregnancy tests at screening including within 24 hours of the start of study treatment. * Willing to practicing at least 1 highly effective method of contraception starting 4 weeks prior to start of study treatment, while receiving study treatment including during any dose interruptions, and for at least 3 months after the last dose of any component of the study treatment. Exclusion Criteria: * Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment. * History of allogenic stem cell transplantation or prior organ transplant requiring immunosuppressive therapy. * Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5. * Myelodysplastic syndrome or any malignancy within 24 months of signing consent. The only exceptions are malignancies treated within the last 24 months that are considered completely cured. * Plasmapheresis ≤28 days of approval. * Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment. * Forced Expiratory Volume in 1 second (FEV1) \<50% of predicted normal. * Concurrent medical or psychiatric condition or disease. * Myocardial infarction ≤6 months of enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function. * Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities. * Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients of daratumumab, lenalidomide, bortezomib or dexamethasone. * Pregnant or breast-feeding females
Where this trial is running
Innsbruck and 30 other locations
- Innsbruck Medical University — Innsbruck, Austria (Not_yet_recruiting)
- Ordensklinikum Linz — Linz, Austria (Recruiting)
- Clinic Ottakring — Vienna, Austria (Not_yet_recruiting)
- Medical University of Vienna — Vienna, Austria (Not_yet_recruiting)
- Universitätsklinikum Hamburg - Eppendorf — Hamburg, Germany (Recruiting)
- Klinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen — München, Germany (Not_yet_recruiting)
- University Hospital of Alexandroupolis — Alexandroupolis, Greece (Recruiting)
- Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens — Athens, Greece (Recruiting)
- St Savvas Cancer Hospital — Athens, Greece (Recruiting)
- Theagenion Cancer Hospital — Thessaloníki, Greece (Recruiting)
- AOU Ospedali Riuniti di Ancona — Ancona, Italy (Recruiting)
- ASST Papa Giovanni XXIII Hospital — Bergamo, Italy (Recruiting)
- A.O.U. di Bologna - Policlinico S. Orsola Malpighi — Bologna, Italy (Not_yet_recruiting)
- A.O.Spedali Civili di Brescia — Brescia, Italy (Recruiting)
- A.O.U. Careggi - Firenze — Firenze, Italy (Recruiting)
- A.O.U. Policlinico S. Martino - Ematologia — Genova, Italy (Not_yet_recruiting)
- Novara Hospital — Novara, Italy (Recruiting)
- Policlinico S. Matteo Fondazione IRCCS - Pavia — Pavia, Italy (Recruiting)
- AUSL-IRCCS di Reggio Emilia Arcispedale S. Maria Nuova — Reggio Emilia, Italy (Recruiting)
- Ospedale "Infermi" di Rimini — Rimini, Italy (Recruiting)
- Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo — San Giovanni Rotondo, Italy (Recruiting)
- A.O. S. Santa Maria Hospital Institute of Oncohematology Terni — Terni, Italy (Not_yet_recruiting)
- A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U — Torino, Italy (Recruiting)
- Ospedale S. Maria della Misericordia di Udine — Udine, Italy (Not_yet_recruiting)
- Amsterdam Medical Center — Amsterdam, Netherlands (Not_yet_recruiting)
- Rijnstate — Arnhem, Netherlands (Recruiting)
- Amphia ziekenhuis — Breda, Netherlands (Not_yet_recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Not_yet_recruiting)
- Dijklander ziekenhuis — Purmerend, Netherlands (Recruiting)
- Erasmus University Medical Center Rotterdam — Rotterdam, Netherlands (Not_yet_recruiting)
- Maasstad Ziekenhuis — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Rosita Ghiraw-Visser
- Email: rosita.ghiraw@emn.org
- Phone: +31 10 703 31 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.