IXAZOMIB REAL-LIFE-SETTING USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA: REMIX, A PROSPECTIVE, NON-INTERVENTIONAL STUDY
Author(s): ,
Lauriane Filliatre-Clément
Affiliations:
CHU de Nancy ,Nancy,France
,
Anne Charvet-Rumpler
Affiliations:
CHU de Besançon ,besancon,France
,
Lofti Benboubker
Affiliations:
CHU de Tours ,Tours,France
,
Anne Marie STOPPA
Affiliations:
Institut Paoli Calmettes ,MARSEILLE,France
,
Philippe RODON
Affiliations:
CH de Périgueux ,PERIGUEUX,France
,
Kamel Laribi
Affiliations:
CH Le Mans ,Le mans,France
,
Laure VIncent
Affiliations:
CHU Montpellier,Montpellier,France
,
Hacène Zerazhi
Affiliations:
CH d'Avignon ,AVIGNON,France
,
PHilippe COLLET
Affiliations:
Institut de Cancérologie Lucien Neuwirth ,ST PRIEST EN JAREZ ,France
,
Valentine RICHEZ
Affiliations:
CHU de Nice ,Nice,France
,
Lionel KARLIN
Affiliations:
CH Lyon Sud,PIERRE BENITE,France
,
Cyrille Hulin
Affiliations:
CHU de boredeaux,BORDEAUX,France
,
Frédéric MALOISEL
Affiliations:
Clinique Sainte Anne ,Strasbourg,France
,
Margaret MACRO
Affiliations:
CHU de Caen,Caen,France
,
Nathalie Texier
Affiliations:
Kappa Santé,PAris,France
,
christos CHOUAD
Affiliations:
CHI de Créteil ,CRETEIL,France
Xavier LELEU
Affiliations:
CHU Poitiers,Poitiers,France
(Abstract release date: 05/14/20) EHA Library. Filliatre-Clément L. 06/12/20; 293526; EP1036
Lauriane Filliatre-Clément
Lauriane Filliatre-Clément
Contributions
Abstract

Abstract: EP1036

Type: e-Poster

Background

Ixazomib (IXA) is an orally-administered proteasome inhibitor approved in Europe in November 2016 for relapsed and/or refractory multiple myeloma (RRMM). It became available in France from May 2017 via a compassionate use program (CUP) and from October 2018 via the classical market access (non-CUP).

Aims

In addition to pivotal clinical trials, real-world evidence (RWE) is required to evaluate effectiveness and safety in clinical routine practices. A non-interventional study, has been conducting in France to evaluate IXA use in combination with lenalidomide and dexamethasone (IRD) in real life. REMIX patients’ characteristics are here-described.

Methods

REMIX is a non-interventional, multicentric, prospective study to assess IRD effectiveness and safety globally and per subgroups (age, previous treatment, frailty as defined by Facon T & al.in Leukemia 2020, renal failure defined as CrCl ≤30 ml/min)). It is conducted in 59 sites (public or private practitioners) in patients with RRMM, initiating IRD in second line or more treatment. After inclusion, patients are assessed every 3 months (mo) during 24 mo then every 6 mo as per standard practice. The total follow-up varies between 24 (for last patient in) and 54 mo (1st patient in).

This interim analysis assessed 1/ patients’ and disease characteristics at IRD initiation, 30 months after the first inclusion and 2/ IXA use and tolerance in the followed-up CUP patients.

Results

Of the 315 Remix patients, 178 and 137 were respectively enrolled in the CUP and non-CUP groups. Median follow up was 12.5 mo for CUP and 4.6 mo for non-CUP patients.

They were 51% of males, with a median age of 72 years (39% ≥75y). 51% were frail and 8% had renal failure. Non-CUP patients were older (median age of 74y vs 70y) and frailer (57% vs 46%). Comorbidities were reported in 62% of patients including diabetes (10%), renal disease (9%), solid tumor (7%). At diagnosis, the cytogenetic risk was standard/high/not known in respectively 47%, 13% and 40% of patients. 9% presented a plasmacytoma. 36% had multiple or severe bone lesions and 22% of peripheral neuropathy. MM was diagnosed at a median of 4 years before IRD initiation.

IRD was initiated for a biological (28%), a clinical +/- biological (57%) relapse or other reasons (15%). The median number of prior treatment lines was 1 (1-11): respectively 1 in 63%, 2 in 18% and 3+ in 19% of patients. Of them, 44% had an history of stem-cell transplantation. 93% had been previously treated with a proteasome inhibitor, 63% with an IMiD including 37% who had received lenalidomide. The median washout period between lenalidomide discontinuation and IRD start was 16 mo. IXA was initiated at a dose of 4 mg in 92% patients associated with lenalidomide 25 mg (64%), 15 mg (17%), 10 mg (11%) or other (8%).

The 166 followed-up CUP patients received a median of 11 IRD cycles. An IXA dosage reduction was reported for 16% of patients and a discontinuation for 40% (n=66), related to AE in 11% of cases (n= 18). Serious adverse events were reported in 26% of patients (n=46), including 5 (3%) SAE considered related to IXA. Most frequent (>10%) AE were thrombocytopenia (25%), diarrhoea (21%), asthenia (14%) anaemia (13%), neutropenia (13%) and nausea (10%).

Conclusion

Few RWE data have been published for IXA use in Europe. IRD is mainly prescribed in elderly, after 1 or 2 lines of treatment, at a 4 mg dosage. A high proportion of patients had already been treated with lenalidomide before initiating IRD. Reported adverse events were consistent with known safety IXA profile. mPFS will be assessed in upcoming analysis.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple myeloma, Proteasome inhibitor

Abstract: EP1036

Type: e-Poster

Background

Ixazomib (IXA) is an orally-administered proteasome inhibitor approved in Europe in November 2016 for relapsed and/or refractory multiple myeloma (RRMM). It became available in France from May 2017 via a compassionate use program (CUP) and from October 2018 via the classical market access (non-CUP).

Aims

In addition to pivotal clinical trials, real-world evidence (RWE) is required to evaluate effectiveness and safety in clinical routine practices. A non-interventional study, has been conducting in France to evaluate IXA use in combination with lenalidomide and dexamethasone (IRD) in real life. REMIX patients’ characteristics are here-described.

Methods

REMIX is a non-interventional, multicentric, prospective study to assess IRD effectiveness and safety globally and per subgroups (age, previous treatment, frailty as defined by Facon T & al.in Leukemia 2020, renal failure defined as CrCl ≤30 ml/min)). It is conducted in 59 sites (public or private practitioners) in patients with RRMM, initiating IRD in second line or more treatment. After inclusion, patients are assessed every 3 months (mo) during 24 mo then every 6 mo as per standard practice. The total follow-up varies between 24 (for last patient in) and 54 mo (1st patient in).

This interim analysis assessed 1/ patients’ and disease characteristics at IRD initiation, 30 months after the first inclusion and 2/ IXA use and tolerance in the followed-up CUP patients.

Results

Of the 315 Remix patients, 178 and 137 were respectively enrolled in the CUP and non-CUP groups. Median follow up was 12.5 mo for CUP and 4.6 mo for non-CUP patients.

They were 51% of males, with a median age of 72 years (39% ≥75y). 51% were frail and 8% had renal failure. Non-CUP patients were older (median age of 74y vs 70y) and frailer (57% vs 46%). Comorbidities were reported in 62% of patients including diabetes (10%), renal disease (9%), solid tumor (7%). At diagnosis, the cytogenetic risk was standard/high/not known in respectively 47%, 13% and 40% of patients. 9% presented a plasmacytoma. 36% had multiple or severe bone lesions and 22% of peripheral neuropathy. MM was diagnosed at a median of 4 years before IRD initiation.

IRD was initiated for a biological (28%), a clinical +/- biological (57%) relapse or other reasons (15%). The median number of prior treatment lines was 1 (1-11): respectively 1 in 63%, 2 in 18% and 3+ in 19% of patients. Of them, 44% had an history of stem-cell transplantation. 93% had been previously treated with a proteasome inhibitor, 63% with an IMiD including 37% who had received lenalidomide. The median washout period between lenalidomide discontinuation and IRD start was 16 mo. IXA was initiated at a dose of 4 mg in 92% patients associated with lenalidomide 25 mg (64%), 15 mg (17%), 10 mg (11%) or other (8%).

The 166 followed-up CUP patients received a median of 11 IRD cycles. An IXA dosage reduction was reported for 16% of patients and a discontinuation for 40% (n=66), related to AE in 11% of cases (n= 18). Serious adverse events were reported in 26% of patients (n=46), including 5 (3%) SAE considered related to IXA. Most frequent (>10%) AE were thrombocytopenia (25%), diarrhoea (21%), asthenia (14%) anaemia (13%), neutropenia (13%) and nausea (10%).

Conclusion

Few RWE data have been published for IXA use in Europe. IRD is mainly prescribed in elderly, after 1 or 2 lines of treatment, at a 4 mg dosage. A high proportion of patients had already been treated with lenalidomide before initiating IRD. Reported adverse events were consistent with known safety IXA profile. mPFS will be assessed in upcoming analysis.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple myeloma, Proteasome inhibitor

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