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JOURNAL ONKOLOGIE – STUDIE
TAURUS

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

Rekrutierend

NCT-Nummer:
NCT06189833

Studienbeginn:
November 2023

Letztes Update:
23.04.2024

Wirkstoff:
Daratumumab, Bortezomib, Lenalidomide, Dexamethasone

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Stichting European Myeloma Network

Collaborator:
Janssen Pharmaceutica

Kontakt

Studienlocations
(3 von 31)

Klinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen
München
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Basserman» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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. (Time Frame - Up to 12 months):
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.



Secondary outcome:

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-induction. (Time Frame - Up to 4 months and 2 weeks):
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.

2. 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. (Time Frame - Up to 12 months):
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.

3. Proportion (%) of agreement and disagreement in the MRD measurements in BM by NGF-MRD and NGS-MRD at post-induction and post-consolidation. (Time Frame - Up to 12 months):
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.

4. MRD negativity rate BM-MRD and PB-MRD (Time Frame - Up to 12 months):
To evaluate the MRD negativity rate achieved at any time up to the end of consolidation with BM based MRD techniques and with the MS-MRD technique

5. ORR, VGPR or better, CR or better, sCR at post-induction, post-transplant, post-consolidation and overall. (Time Frame - Up to 12 months):
ORR will be defined as the percentage of participants achieving confirmed PR or better (i.e., PR+VGPR+CR+sCR). The number and percentage of participants achieving ORR, VGPR or better, CR or better and sCR will be presented, post-induction, post-consolidation, post-transplant and overall.

6. Effect of cytogenetic abnormalities (presence or not), R-ISS (1, 2 or 3), CTCs (number of cells per ml) on likelihood to develop MRD-negative disease (with MS, NGS and NGF) and the agreement between the different techniques. (Time Frame - Up to 12 months):
Binary logistic regression will be used to identify factors associated with post-induction and post-consolidation MRD status (negative or positive) (as defined with NGS-MRD; NGF-MRD; MS-MRD; the most conservative method), in the MRD-evaluable Analysis Set. Odds ratios and respective 95% CIs will be estimated from univariable and multivariable models.

Geprüfte Regime

  • Daratumumab (JNJ-54767414):
    Daratumumab will be administered via a subcutaneous injection (SC)
  • Bortezomib (Velcade):
    Bortezomib will be administered via a subcutaneous injection (SC)
  • Lenalidomide:
    Lenalidomide will be administered orally
  • Dexamethasone:
    Dexamethasone will be administered orally

Quelle: ClinicalTrials.gov


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