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Recruiting Phase 3 NCT05519085

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Phase 3 – large-scale trial before approval
Conditions: Relapsed or Refractory Multiple Myeloma

Sponsor: Celgene

trial.available_in: БГ
Overview
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
Who can participate
Inclusion Criteria \- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:. i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or. ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP). iii) For participants 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. * Participants received 1 to 3 prior lines of antimyeloma therapy. * Participants achieved minimal response \[MR\] or better to at least 1 prior antimyeloma therapy. Exclusion Criteria \- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:. i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded. ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded. * For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity. * Participant has had prior treatment with mezigdomide or pomalidomide. * Other protocol-defined Inclusion/Exclusion criteria apply.
Locations 27
Argentina (1)
Local Institution - 0318
Chivilcoy , Buenos Aires
ACTIVE_NOT_RECRUITING
Australia (1)
Local Institution - 0055
Liverpool , New South Wales
ACTIVE_NOT_RECRUITING
Belgium (1)
Ziekenhuis Oost-Limburg, Campus St.-Jan
Genk , Limburg
Natalie Put, Site 0138
Brazil (1)
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador , Estado de Bahia
EDVAN CRUSOE, Site 0046
Canada (1)
Local Institution - 0225
Greenfield Park , Quebec
ACTIVE_NOT_RECRUITING
Chile (1)
Local Institution - 0329
Santiago , Santiago Metropolitan
ACTIVE_NOT_RECRUITING
China (1)
Local Institution - 0062
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
Czech Republic (1)
Fakultní nemocnice Brno Bohunice
Brno , Brno-město
Finland (1)
Kuopion Yliopistollinen Sairaala
Kuopio , Northern Savonia
Anu Partanen, Site 0256
France (1)
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg , Alsace
Cécile SONNTAG, Site 0175
Germany (1)
TUM Klinikum
München , Bavaria
Marion Hoegner, Site 0392
Greece (1)
Evangelismos General Hospital of Athens
Athens , Attikí
Sosana Delimpasi, Site 0190
India (1)
HCG Aastha Cancer Centre
Ahmedabad , Gujarat
Abhishek Dudhatra, Site 0342
Ireland (1)
University College Hospital - Galway
Galway , Connacht
Janusz Krawczyk, Site 0121
Israel (1)
Meir Medical Center
Kfar Saba , Central District
Osnat Jarchowsky Dolberg, Site 0196
Italy (1)
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola , Emilia-Romagna
DAVIDE NAPPI, Site 0384
Japan (1)
National Cancer Center Hospital East
Kashiwa , Chiba
Junichiro Yuda, Site 0281
New Zealand (1)
Local Institution - 0335
Tauranga , Bay of Plenty
ACTIVE_NOT_RECRUITING
Poland (1)
Local Institution - 0346
Skórzewo , Greater Poland Voivodeship
WITHDRAWN
Puerto Rico (1)
Local Institution - 0355
San Juan
WITHDRAWN
Romania (1)
Fundeni Clinical Institute
Bucharest
Sorina Badelita, Site 0021
South Africa (1)
Netcare Pretoria East Hospital
Centurion , GP
LUCILLE SINGH, Site 0405
South Korea (1)
Local Institution - 0106
Busan , Busan
WITHDRAWN
Spain (1)
Local Institution - 0183
Palma , Balearic Islands
WITHDRAWN
Turkey (1)
Ankara University Health Practice and Research Hospitals
Ankara
Guldane Cengiz Seval, Site 0232
United Kingdom (1)
Addenbrooke's Hospital
Cambridge , Cambridgeshire
Marquita Camilleri, Site 0326
United States (1)
Cancer and Blood Specialty Clinic
Los Alamitos , California
Vu Phan, Site 0366
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.09.2022
Completion date
30.11.2033
Registry ID
NCT05519085
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.