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Spots Global Cancer Trial Database for IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic

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Trial Identification

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

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Xavier LELEU, Pr

Affiliation: Poitiers University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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