Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS

NCT06189833 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EMN33/54767414MMY2089
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 31

Brief Summary

This is a multicenter, single arm, open-label, Phase 2 study in mutiple myeloma with newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. The study is evaluating a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using blood samples and compares it with the minimal residual disease (MRD) technique using bone marrow samples.

Conditions

Multiple Myeloma

Keywords

MS-MRD

Outcome Measures

Primary Outcomes (1)

• Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-consolidation.

  The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.

  Up to 12 months

Secondary Outcomes (6)

• Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-induction.

  Up to 4 months and 2 weeks

• Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGF-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-induction and post-consolidation.

  Up to 12 months

• Proportion (%) of agreement and disagreement in the MRD measurements in BM by NGF-MRD and NGS-MRD at post-induction and post-consolidation.

  Up to 12 months

• MRD negativity rate BM-MRD and PB-MRD

  Up to 12 months

• ORR, VGPR or better, CR or better, sCR at post-induction, post-transplant, post-consolidation and overall.

  Up to 12 months

Study Arms (1)

D-VRd + ASCT + DVRD

EXPERIMENTAL

Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRD) for 4 induction cycles prior to and 2 consolidation cycles following autologous stem cell transplantation. Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6 Bortezomib SC 1.3mg/m2 on days 1, 8, 15, 22 of cycle 1-6 Lenalidomide orally 25 mg once daily on days 1-21 of cycle 1-6 Dexamethasone 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22 and 23 of cycle 1-6

Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Daratumumab DRUG

Daratumumab will be administered via a subcutaneous injection (SC)

Also known as: JNJ-54767414

D-VRd + ASCT + DVRD

Bortezomib DRUG

Bortezomib will be administered via a subcutaneous injection (SC)

Also known as: Velcade

D-VRd + ASCT + DVRD

Lenalidomide DRUG

Lenalidomide will be administered orally

D-VRd + ASCT + DVRD

Dexamethasone DRUG

Dexamethasone will be administered orally

D-VRd + ASCT + DVRD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stichting European Myeloma Network: lead
• Janssen Pharmaceutica: collaborator

Study Sites (31)

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

Alexandroupoli, 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

Thessaloniki, 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

Florence, 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, 10126, 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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; Bortezomib; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Rosita Ghiraw-Visser

CONTACT

+31 10 703 31 23; rosita.ghiraw@emn.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 5, 2024
• Study Start: November 23, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

AU (4); GR (4); DE (2); NL (7); IT (14)