Letzte Aktualisierung: 06.05.2026

Hämatologische Erkrankungen

Successor 1

Aktive Studien

Studieninformationen

Zweistufige, randomisierte, multizentrische, unverblindete Phase-3-Studie zum Vergleich von CC-92480, Bortezomib und Dexamethason (480Vd) gegenüber Pomalidomid, Bortezomib und Dexamethason (PVd) bei Teilnehmern mit rezidiviertem oder refraktärem multiplem Myelom (RRMM)

Behandlungszentren im CIO

Aachen


Bonn


Ziele

Primäres Prüfziel

To compare the progression-free survival (PFS) of CC-92480 (also known as BMS-986348), bortezomib and dexamethasone (480Vd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)

Sekundäre Prüfziele für die Behandlungsarme:

In Stage 1, to determine the dose of CC-92480 in combination with bortezomib and dexamethasone to continue in Stage 2 of the study - In Stage 1, to determine the plasma concentrations of CC-92480 in combination with bortezomib and dexamethasone - To compare overall survival (OS) between 480Vd and PVd in subjects with RRMM • To evaluate additional efficacy parameters in subjects with RRMM treated with 480Vd compared to PVd - To evaluate minimal residual disease (MRD) negativity rate in subjects treated with 480Vd compared to those treated with PVd - To evaluate safety of 480Vd compared to PVd in subjects with RRMM - In subjects randomized to Stage 2, to evaluate cancer-related symptoms and healthrelated quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) and the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) in subjects treated with 480Vd compared to PVd


Design

Design

Phase

III

Zentren

Multizentrisch

Datenerhebung

Prospektiv

Interventionsgruppen

Zweiarmig

Verblindung

Open-Label

Erkrankung

Diagnose

Hämatologische Erkrankungen, Multiples Myelom [C90]

Diagnosenbeschreibung

Relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior lines of antimyeloma therapy.

Mutation

Patienten

Alter

18+ Jahre

Einschlusskriterien

Auswahl: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject has documented diagnosis of MM and measurable disease, defined as any of the following: a. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or b. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or, c. For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio. 3. Subject has received 1 to 3 prior lines of antimyeloma therapy. (Note: One line can contain several phases [eg, induction, (with or without) hematopoietic stem cell transplant, (with or without) consolidation, and/or (with or without) maintenance therapy) See APPENDIX J. 4. Subject must have received prior treatment with a lenalidomide-containing regimen. 5. Subject must have documented disease progression during or after their last antimyeloma regimen.

Ausschlusskriterien

Auswahl: 1. Subject who has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor. 2. For subjects with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or subject discontinued bortezomib due to toxicity. 3. Subject has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating study treatment.

Therapie

Intervention

Substanz

Zuständige Gesamtstudie

Sponsor

Leiter der klinischen Prüfung (LKP)

Studiengruppen/-zentrale

Kontakt Klinische Studien

CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490

CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036

CIO Köln: Uniklinik Köln, +49 (0) 221 478-0

CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)