A clinical study comparing treatment with Iberdomide, Daratumumab, and Dexamethasone to treatment with Daratumumab, Bortezomib, and Dexamethasone in patients with a refractory or progressing blood cancer called Multiple Myeloma (RRMM) (EXCALIBER-RRMM)
Zusammenfassung der Studie
The aim of this study is to compare the efficacy of a new investigational drug, Iberdomide (CC-220) in combination with Daratumumab and Dexamethasone (IberDd) for the treatment of relapsed or refractory Multiple Myeloma with that of Daratumumab, Bortezomib, and Dexamethasone. In this study, the safety and efficacy of the Iberdomide combination will be tested against the other combination in a large number of patients, and it will be examined how patients feel about their treatment for Multiple Myeloma and how their health-related quality of life is. Approximately 864 participants will take part in this study worldwide. In Switzerland, about 6 participants will take part in the study at 2 centers. The expected duration of the study is as long as the disease does not worsen and as long as the patients tolerate the study treatment.
(BASEC)
Untersuchte Intervention
In Phase 1 of the study, at least 200 participants with RRMM will be randomized 1:1:1:1 to treatment arms A1, A2, A3 (IberDd) and treatment arm B (DVd). In Phase 2 of the study, approximately 664 participants with RRMM will be randomized 1:1 between treatment arm A (IberDd) and treatment arm B (DVd). Phase 1 treatment arms A1, A2, A3 and Phase 2 treatment arm A (IberDd) will receive treatment with Iberdomide, Daratumumab, and Dexamethasone: Iberdomide capsules will be taken at home on days 1-21 of each 28-day cycle. Dexamethasone tablets will be taken at home. The dose and dosing schedule depend on age, weight, and/or medical history. Daratumumab will be injected subcutaneously in the clinic. The frequency of Daratumumab administration depends on the treatment cycle the patient is in. Treatment arm A (DVd) will receive treatment with Daratumumab, Bortezomib, and Dexamethasone: Daratumumab subcutaneously (injection) in the clinic. The frequency of Daratumumab administration depends on the treatment cycle the patient is in. Bortezomib will be injected subcutaneously in the clinic until the end of cycle 7. The dose of Bortezomib depends on weight and height, which will be monitored regularly. Dexamethasone tablets will be taken at home. The dose and dosing schedule depend on age, weight, and/or medical history.
(BASEC)
Untersuchte Krankheit(en)
Multiple Myeloma, a cancer of plasma cells (a type of immune cell that produces antibodies) from the bone marrow, which has either returned after the last treatment (relapsed) or has not responded to the last treatment (refractory).
(BASEC)
The main inclusion criteria are: - documented diagnosis of MM and measurable disease - prior receipt of 1 to 2 prior cycles of anti-myeloma therapy - achieved response (partial response [PR] or better) to at least 1 prior anti-myeloma therapy. (BASEC)
Ausschlusskriterien
The main exclusion criteria are: - infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 14 days for mild or asymptomatic infection or within 28 days for severe/critical illness - certain laboratory abnormalities, e.g., in blood counts, liver values, or kidney values - peripheral neuropathy grade 3, grade 4, or grade 2 with pain (BASEC)
Studienstandort
Chur, St Gallen
(BASEC)
Sponsor
Celgene Corporation
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
David Walter Pignolet
+41 32729 x8526
David.Pignolet@clutterbms.comCELGENE
(BASEC)
Wissenschaftliche Auskünfte
Bristol-Myers Squibb,
855-907-3286
David.Pignolet@clutterbms.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
08.04.2022
(BASEC)
ICTRP Studien-ID
NCT04975997 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A PHASE 3, TWO-STAGE, RANDOMIZED, MULTICENTER, OPEN-LABEL STUDY COMPARING IBERDOMIDE, DARATUMUMAB AND DEXAMETHASONE (IberDd) VERSUS DARATUMUMAB, BORTEZOMIB, AND DEXAMETHASONE (DVd) IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) (EXCALIBER-RRMM) (BASEC)
Wissenschaftlicher Titel
A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) (ICTRP)
Öffentlicher Titel
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ICTRP)
Untersuchte Krankheit(en)
Multiple Myeloma (ICTRP)
Untersuchte Intervention
Drug: DexamethasoneDrug: DaratumumabDrug: BortezomibDrug: IberdomideDrug: IberdomideDrug: IberdomideDrug: DexamethasoneDrug: Daratumumab (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria
- Documented diagnosis of multiple myeloma (MM) and measurable disease.
- Received 1 to 2 prior lines of anti-myeloma therapy.
- Must have documented disease progression during or after their last anti-myeloma
regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Exclusion Criteria
- Any condition that confounds the ability to interpret data from the study.
- Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome
(polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin
changes), or clinically significant amyloidosis.
- Known central nervous system involvement with MM.
- Prior therapy with iberdomide.
- Other protocol-defined Inclusion/Exclusion criteria apply. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Progression-free Survival (PFS);Minimal Residual Disease (MRD) negative Complete Response (CR) at any time (ICTRP)
Overall Survival (OS);Sustainability of Minimal Residual Disease (MRD) negativity;Overall Response Rate (ORR);Time to response (TTR);Duration of Response (DoR);Time to Progression (TTP);Time to Next Treatment (TTNT);Progression-free Survival 2 (PFS2);Safety;European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30);European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20);Recommended iberdomide dose for Stage 2;Area under the plasma concentration-time curve from time zero to tau (AUC(TAU));Maximum plasma concentration (Cmax);Time to maximum plasma concentration (Tmax) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Bristol-Myers Squibb;BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, Clinical.Trials@bms.com, 855-907-3286, Bristol-Myers Squibb, (ICTRP)
Sekundäre IDs
U1111-1260-2872, 2020-000431-49, CC-220-MM-002 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04975997 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar