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A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).

4. Juni 2026 aktualisiert von: Peng Liu, Shanghai Zhongshan Hospital

A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL)

The goal of this clinical trial is to learn if teclistamab in combination with daratumumab (Tec-Dara) works to treat newly diagnosed multiple myeloma with concurrent light chain amyloidosis (MM+AL). It will also learn about the safety of this combination. The main questions it aims to answer are:

Does Tec-Dara improve the 1-year progression-free survival rate compared to historical data (50% to 75%) in MM+AL patients? What are the rates of hematologic response (ORR, VGPR, CR, MRD negativity) and organ response in MM+AL patients treated with Tec-Dara? What medical problems do participants have when taking Tec-Dara?

Participants will:

Receive teclistamab subcutaneous injection with step-up dosing (0.06, 0.3, 1.5 mg/kg), followed by 1.5 mg/kg weekly in Cycle 1, 3.0 mg/kg every 2 weeks in Cycles 2-3, and 3.0 mg/kg every 4 weeks in Cycles 4-24 Receive daratumumab subcutaneous injection 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24 Continue treatment until disease progression, unacceptable toxicity, or a maximum of 24 cycles Undergo disease assessments every 28 days (±7 days) including laboratory tests for hematologic and organ response evaluation Provide bone marrow samples for MRD and RNA sequencing analysis

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
      • Shanghai, China
        • Rekrutierung
        • Zhongshan Hospital Fudan University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Age ≥18 years, any sex/gender
  2. Diagnosis of multiple myeloma according to IMWG criteria

  3. Histopathologic diagnosis of AL amyloidosis confirmed by:

    • Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:

      1. Immunohistochemistry and/or immunofluorescence
      2. Mass spectrometry
      3. Electron microscopy/immunoelectron microscopy
  4. Measurable disease at screening
  5. Newly diagnosed, no prior anti-plasma cell therapy

  6. Adequate laboratory values:

    • Hemoglobin ≥7.5 g/dL
    • Absolute neutrophil count ≥1.0×10⁹/L
    • Platelet count ≥70×10⁹/L (platelet transfusion acceptable; >50×10⁹/L if ≥50% bone marrow nucleated cells are plasma cells)
    • ALT ≤2.5× upper limit of normal (ULN)
    • AST ≤2.5× ULN
    • Total bilirubin ≤2.0× ULN
    • Creatinine clearance ≥30 mL/min
    • Corrected serum calcium ≤14 mg/dL
  7. Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study
  8. Voluntarily signed informed consent form (ICF)

Exclusion Criteria:

  1. Prior anti-myeloma therapy or stem cell transplantation
  2. Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary AL amyloidosis without concurrent MM, Waldenström macroglobulinemia, plasma cell leukemia, POEMS syndrome, or other malignancies within 3 years prior to enrollment
  3. Active infection or autoimmune disease
  4. Uncontrolled diabetes, hypertension, or other comorbidities
  5. Pregnant or lactating female
  6. Currently participating in another interventional study
  7. Any other condition that the investigator considers unsuitable for study participation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Treatment Group

Teclistamab (subcutaneous injection) with step-up dosing: 0.06 mg/kg, 0.3 mg/kg, and 1.5 mg/kg on Days 1, 3, and 5 of Cycle 1, followed by 1.5 mg/kg weekly in Cycle 1, 3.0 mg/kg every 2 weeks in Cycles 2-3, and 3.0 mg/kg every 4 weeks in Cycles 4-24.

Daratumumab (subcutaneous injection) 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24.

Treatment continues until disease progression, unacceptable toxicity, or a maximum of 24 cycles (approximately 2 years).
Arzneimittel: Teclistamab

Teclistamab: A humanized IgG4-PAA bispecific antibody targeting BCMA and CD3. It bridges malignant plasma cells and CD3+ T cells, leading to T cell activation and perforin/granzyme-mediated lysis of BCMA+ tumor cells.

Daratumumab: A humanized IgG1κ monoclonal antibody targeting CD38, which induces tumor cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis. It also enhances T cell-mediated anti-myeloma immunity by increasing cytotoxic T helper cells and depleting CD38+ immunoregulatory cells, thereby potentiating teclistamab's activity.

Andere Namen:
  • Daratumumab

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
1-Year Progression-Free Survival (PFS) Rate
Zeitfenster: From the start of treatment to 1 year, or until disease progression or death, whichever occurs first
The percentage of participants who are alive and free from disease progression at 1 year after initiation of Tec-Dara treatment. Progression is defined according to IMWG criteria, including increase in serum M protein, urine M protein, or serum free light chain; development of new bone lesions or soft tissue plasmacytomas; or hypercalcemia.
From the start of treatment to 1 year, or until disease progression or death, whichever occurs first

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hematologic Complete Response (Heme-CR) rate
Zeitfenster: Up to 24 cycles (approximately 2 years)
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response. Heme-CR rate is the percentage of participants who achieve CR prior to subsequent anti-myeloma therapy, during or after the study treatment.
Up to 24 cycles (approximately 2 years)
Very Good Partial Response or Better (≥VGPR) Rate
Zeitfenster: Up to 24 cycles (approximately 2 years)
Heme-VGPR is defined as a reduction in the dFLC to <40 mg/L. ≥VGPR rate is the percentage of participants achieving VGPR and CR prior to subsequent anti-myeloma therapy during or after the study treatment.
Up to 24 cycles (approximately 2 years)
Minimal Residual Disease (MRD) Negativity Rate
Zeitfenster: 6 months and 12 months, and up to 24 cycles (approximately 2 years)
Proportion of participants achieving MRD negativity at a sensitivity threshold of 10^-5, assessed by next-generation flow cytometry (NGF) or next-generation sequencing (NGS). The MRD-negativity rate by 6 and 12 months will be reported descriptively.
6 months and 12 months, and up to 24 cycles (approximately 2 years)
Organ Response Rate
Zeitfenster: Up to 24 cycles (approximately 2 years)
Proportion of participants achieving organ response according to consensus criteria for AL amyloidosis, based on changes in NT-proBNP, cardiac troponin T/I, and estimated glomerular filtration rate (eGFR).
Up to 24 cycles (approximately 2 years)
Time to First Response
Zeitfenster: Up to 24 cycles (approximately 2 years)
Time from the start of treatment to the first documented PR or better response according to IMWG criteria.
Up to 24 cycles (approximately 2 years)
Duration of Response
Zeitfenster: Up to 3 years from study start
Time from the start of treatment to death from any cause.
Up to 3 years from study start
Median Progression-Free Survival
Zeitfenster: Up to 3 years from study start
Time from the start of treatment to disease progression or death from any cause, whichever occurs first.
Up to 3 years from study start
Time to Next Treatment
Zeitfenster: Up to 3 years from study start
Time from the start of treatment to the initiation of first subsequent anti-myeloma therapy.
Up to 3 years from study start
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Zeitfenster: Through study completion, up to 12 months after the end of study treatment.
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0. A participant with multiple adverse events of the same preferred term will be counted once. Adverse events will be summarized by frequency, severity (graded by CTCAE v5.0), and causality, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, hematologic toxicities, and infusion-related reactions.
Through study completion, up to 12 months after the end of study treatment.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Differential gene expression in bone marrow by RNA sequencing between baseline and disease progression in MM-AL patients.
Zeitfenster: Baseline and up to 3 years.
Bone marrow transcriptome profiles will be analyzed by RNA sequencing at baseline and at disease progression to identify differentially expressed genes, altered signaling pathways, and molecular signatures predictive of disease progression in MM-AL patients. Data will be summarized as fold-change in gene expression, pathway enrichment scores, and predictive model performance metrics (e.g., AUC, sensitivity, specificity).
Baseline and up to 3 years.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai Zhongshan Hospital

Mitarbeiter

Johnson & Johnson

Ermittler

  • Hauptermittler: Peng Liu, Fudan University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

22. Mai 2026

Primärer Abschluss (Geschätzt)

30. Juli 2028

Studienabschluss (Geschätzt)

30. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

21. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SHZS-MMAL-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All IPD that underlie results in a publication

IPD-Sharing-Zeitrahmen

starting 6 months after publication

IPD-Sharing-Zugriffskriterien

IPD could be requested by contacting the corresponding author via email after publication.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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