Carfilzomib In Combination With Bendamustine And Dexamethasone In Refractory Or Relapsed Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT02056756|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2014
Last Update Posted : August 2, 2018
Open-label phase Ib/II, multicenter, international non-comparative trial. This study is designed to determine the safety and efficacy of the novel salvage regimen (CBd) followed by a carfilzomib maintenance in patients with relapsed or refractory multiple myeloma.
Patients will be evaluated at scheduled visits in up to 4 study periods:
pretreatment, treatment, maintenance and long-term follow-up (LTFU).
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Carfilzomib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CARFILZOMIB IN COMBINATION WITH BENDAMUSTINE AND DEXAMETHASONE IN REFRACTORY OR RELAPSED MULTIPLE MYELOMA - A MULTICENTER PHASE IB/II TRIAL OF THE EUROPEAN MYELOMA NETWORK TRIALIST GROUP (EMNTG)|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||February 2021|
Other Name: Krypolis
- Identification of dose-limiting toxicity (DLT) [ Time Frame: 1 year ]
DLTs are defined as the following:
Any CTCAE grade ≥3 non-hematologic event except the following:
1. Nausea or vomiting that responds symptomatic therapy.
- Grade 4 neutropenia lasting more than 7 days.
- Grade 4 hematologic toxicity except neutropenia
- Development of febrile neutropenia defined as grade 3-4 neutropenia with fever 38.5°C and/or infection requiring antibiotic or antifungal treatment. Assessment of DLT defining adverse events will be performed after completion of the second cycle (only in phase Ib) according to the National Cancer Institute Common Terminology Criteria of Adverse Events (CTCAE version 4.0). Efficacy will be assessed by considering VGPR following the proposed regimen, according to the criteria of the International Myeloma Working Group
- Determine the rate of very good partial response (VGPR) or more with the CBd association: [ Time Frame: 1 year ]Determine the rate of very good partial response (VGPR) or more with the CBd association: a VGPR rate of 20% (p0) is considered not promising (H0) and a 40% (p1) as interesting (phase II).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056756
|Universitätsklinikum Schleswig-Holstein (UKSH) - Division of Stem Cell Transplantation and Immunotherapy, 2nd Department of Medicine|
|Kiel, Germany, 24105|
|Torino, TO, Italy, 10126|
|Divisione di Ematologia A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona|
|Ancona, Italy, 60126|