A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
St Vincent's Hospital Melbourne 3065 Fitzroy AustraliaRekrutierend» Google-MapsEpworth Freemasons 3002 Melbourne AustraliaRekrutierend» Google-MapsThe Alfred Hospital 3004 Melbourne AustraliaRekrutierend» Google-MapsEpworth Hospital 3121 Richmond AustraliaNoch nicht rekrutierend» Google-MapsQEII Health Sciences Centre B3H 2Y9 Halifax CanadaRekrutierend» Google-MapsPrincess Margaret Cancer Centre M5G 2M9 Toronto CanadaRekrutierend» Google-MapsFakultní nemocnice Brno Bohunice 625 00 Brno CzechiaRekrutierend» Google-MapsFakultni nemocnice Ostrava 708 52 Ostrava CzechiaRekrutierend» Google-MapsFakultni nemocnice Olomouc 779 00 Olomouc CzechiaNoch nicht rekrutierend» Google-MapsFakultni nemocnice Olomouc 779 00 Olomouc CzechiaRekrutierend» Google-MapsVseobecna fakultni nemocnice v Praze 12808 Praha 2 CzechiaRekrutierend» Google-MapsInstitut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE 31100 Toulouse FranceNoch nicht rekrutierend» Google-MapsCentre Hospitalier Universitaire de Poitiers 86021 Poitiers FranceNoch nicht rekrutierend» Google-MapsCentre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu 44093 Cedex 1 Nantes FranceRekrutierend» Google-MapsEvangelismos General Hospital of Athens 106 76 Athens GreeceRekrutierend» Google-MapsAlexandra General Hospital of Athens 115 28 Athens GreeceRekrutierend» Google-MapsUniversity Hospital of Ioannina 455 00 Ioannina GreeceNoch nicht rekrutierend» Google-MapsSoroka Medical Center 8410101 Be'er Sheva IsraelNoch nicht rekrutierend» Google-MapsRabin Medical Center 4910021 Petah-Tikva IsraelNoch nicht rekrutierend» Google-MapsThe Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric 5265601 Ramat Gan IsraelNoch nicht rekrutierend» Google-MapsSourasky Medical Center 6423906 Tel Aviv IsraelNoch nicht rekrutierend» Google-MapsHadassah Medical Center 9112001 Jerusalem IsraelNoch nicht rekrutierend» Google-MapsAUSL di Piacenza 29121 Piacenza ItalyRekrutierend» Google-MapsOspedale Santa Maria delle Croci 48121 Ravenna ItalyRekrutierend» Google-MapsIRCCS Casa Sollievo della Sofferenza 71013 San Giovanni Rotondo ItalyNoch nicht rekrutierend» Google-MapsIRCCS Casa Sollievo della Sofferenza 71013 San Giovanni Rotondo ItalyNoch nicht rekrutierend» Google-MapsFondazione IRCCS San Gerardo dei Tintori 20900 Monza ItalyNoch nicht rekrutierend» Google-MapsAzienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino 10126 Torino ItalyNoch nicht rekrutierend» Google-MapsA.O.U. 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1. Part 1 Dose Limiting Toxicity (Time Frame - From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide)
2. Part 2: Progression free survival by blinded independent central review (Time Frame - From randomization up to 79 months.)
3. Part 2: Minimal Residual Disease negativity rate (Time Frame - At 12 months after randomization)
Secondary outcome:
1. Overall Survival (Time Frame - From date of randomization up to 79 months)
2. Overall minimal residual disease negativity rate (Time Frame - From date of randomization up to 79 months)
3. Sustained MRD negativity rate (Part 2) (Time Frame - From date of randomization up to 79 months)
4. Duration of minimal residual disease negativity (Part 2) (Time Frame - From date of minimal residual disease negative status up to 79 months)
5. PFS by investigator (Time Frame - From date of randomization up to 79 months)
6. PFS2 by investigator (Part 2) (Time Frame - From the date of randomization up to 79 months)
7. Objective Response Rate (Time Frame - From the date of randomization up to 79 months)
8. Complete Response Rate (Time Frame - From the date of randomization up to 79 months)
9. Time to Response (Time Frame - From the date of randomization to date of confirmed objective response up to 79 months)
10. Duration of Response (Time Frame - From the date of confirmed objective response up to 79 months)
11. Duration of Complete Response (Time Frame - From the date of confirmed complete response up to 79 months)
12. Frequency of treatment-emergent adverse events (Time Frame - From the date of first dose of study intervention up to 79 months)
13. Frequency of abnormal laboratory results (Time Frame - From the date of first dose of study intervention up to 79 months)
14. Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations (Time Frame - From date of first dose of study intervention up to 79 months): Predose and post dose concentrations of elranatamab
15. Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab (Time Frame - From date of first dose of study intervention up to 79 months): Immunogenicity of elranatamab
16. Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1) (Time Frame - From date of first dose of study intervention up to 79 months): Predose concentrations of daratumumab and lenalidomide
17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2) (Time Frame - From date the informed consent is signed up to 79 months): Higher scores on the functional scales represent higher levels of functioning. Higher
scores on the global health status/quality of life scale represent higher health
status/quality of life. Higher scores on the symptom scales/items represent a greater
presence of symptoms.
18. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Myeloma 20 (Part 2) (Time Frame - From date the informed consent is signed up to 79 months): Higher scores on the functioning subscales (body image, future perspective) represent
higher levels of functioning, whereas higher scores on the symptom subscales (disease
symptoms, side effects) represent a greater presence of symptoms
Elranatamab: Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Daratumumab: Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide: Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Dexamethasone: Randomized
Quelle: ClinicalTrials.gov
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"A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant"
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