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Brief Title: IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic
Official Title: Multicenter Open Label Phase 2 Single Arm Study of Ixazomib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Characterized With Genomic Abnormalities of Adverse Adverse Prognostic
Study ID: NCT03683277
Brief Summary: This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities.
Detailed Description: There is no escalation dose study, the maximum tolerated dose has already been determined in previous phase 1 escalation dose studies. The proposed dose of dexamethasone is considered standard. Patients will receive the IPd regimen until progression. The hypothesis is that this IPd regimen based combination will eventually improve time to disease progression, with no additional toxicity, as compared to other available regimens, in this subgroup of patients with myeloma characterized with a very adverse prognosis. Study design. This trial will study the efficacy and safety of IPd regimen in Relapsed and Refractory Multiple Myeloma with adverse Genomic Abnormalities until progression in 2 separate phases. * Induction phase: 17 cycles - 21-days cycles Ixazomib 3 mg D1, D4, D8 and D11 Pomalidomide 4mg D1 to D14 Dexamethasone 40 mg/d D1, D8 and D15 if patient aged \<75 years Dexamethasone 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years * Maintenance phase: until progression - 28-days cycles Ixazomib 4mg D1, D8 and D15 Pomalidomide 4mg D1 to D21 * It is not planned for the patients to receive autologous stem-cell transplantation as part of the study trial
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU Angers, Angers, , France
CH Avignon - Centre Hospitalier H.Duffaut, Avignon, , France
Centre hospitalier de la côte basque, Bayonne, , France
Hôpital Avicenne, Bobigny, , France
CHU de Caen, Caen, , France
Hôpital Privé Sévigné, Cesson-Sévigné, , France
CHU Henri Mondor, Créteil, , France
CHU de Dijon, Dijon, , France
Centre hospitalier de Dunkerque, Dunkerque, , France
CHU de Grenoble, Grenoble, , France
Centre hospitalier départemental de Vendée, La Roche-sur-Yon, , France
CHRU Hôpital Claude Huriez, Lille, , France
CHU de Limoges, Limoges, , France
CHU Saint Eloi, Montpellier, , France
CHRU Hôtel Dieu, Nantes, , France
Hôpital de l'Archet 1, Nice, , France
Hôpital Saint Louis, Paris, , France
CHU Bordeaux - Hôpital Haut Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
CHU de Poitiers, Poitiers, , France
Centre Hospitalier de Périgueux, Périgueux, , France
CHU de Reims Hôpital Robert Debré, Reims, , France
CHU Pontchaillou, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Institut de cancérologie Strasbourg Europe (ICANS), Strasbourg, , France
Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, , France
CHRU Bretonneau, Tours, , France
Hôpitaux de Brabois - CHRU de Nancy, vandoeuvre les Nancy, , France
Name: Xavier LELEU, Pr
Affiliation: Poitiers University Hospital
Role: PRINCIPAL_INVESTIGATOR