Dienstag, 15. Juni 2021
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JOURNAL ONKOLOGIE – STUDIE
IONA-MM

A Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Rekrutierend

NCT-Nummer:
NCT04458831

Studienbeginn:
August 2020

Letztes Update:
27.05.2021

Wirkstoff:
isatuximab SAR650984, Pomalidomide, Dexamethasone, Carfilzomib

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Sanofi

Collaborator:
-

Studienleiter

Clinical Sciences & Operations
Study Director
Sanofi

Kontakt

Trial Transparency email recommended (Toll free number for US & Canada)
Kontakt:
Phone: 800-633-1610
Phone (ext.): option 6
E-Mail: Contact-Us@sanofi.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 37)

Investigational Site Number 2760014
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760016
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760025
04924 Bad Liebenwerda
(Brandenburg)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760020
96052 Bamberg
(Bayern)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760003
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760009
10715 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760007
86609 Donauwörth
(Bayern)
GermanyRekrutierend» Google-Maps
Investigational site number 2760001
44263 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760010
60389 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760015
38642 Goslar
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760012
30449 Hanover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760013
82211 Herrsching Am Ammersee
(Bayern)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760008
04289 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760006
81241 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760021
26121 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760019
97080 Würzburg
(Bayern)
GermanyRekrutierend» Google-Maps
Investigational Site Number 8400008
92835 Fullerton
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400009
94143 San Francisco
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400007
32204 Jacksonville
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400023
33805 Lakeland
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400025
33024 Pembroke Pines
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400019
67846 Garden City
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400010
48334 Farmington Hills
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400006
65613 Bolivar
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400016
64114 Kansas City
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400017
07728 Freehold
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400024
07731 Howell
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400018
07739 Little Silver
United StatesRekrutierend» Google-Maps
Investigational Site Number 84000015
44708 Canton
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400012
44646 Massillon
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400020
29414 Charleston
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400011
29615 Greenville
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400013
77030 Houston
United StatesRekrutierend» Google-Maps
Investigational site number 400002
4400 Steyr
AustriaRekrutierend» Google-Maps
Investigational Site Number 3920005
701-1192 Okayama
JapanRekrutierend» Google-Maps
Investigational Site Number 3920001
990-9585 Yamagata-shi
JapanRekrutierend» Google-Maps
Investigational Site Number 8400001
00917 Hato Rey
Puerto RicoRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Duration per participant is 2.5 years

Ein-/Ausschlusskriterien

Age ≥18 years

- Patients with RRMM who have at least one prior line of therapy

- Patients for whom the treating physician has made the decision to initiate isatuximab

per routine practice and independently of the purpose of the study; for

retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of

three months prior to study enrollment

- Able to understand and complete the study-related questionnaires

- Patient must have given signed informed consent prior to study start. For

retrospectively enrolled patients who are deceased at the date of enrollment into the

study, a waiver of consent will be required; patients who have started and stopped

treatment up to three months before ICF are eligible .

Most important exclusion criteria for potential participants:

Patients who are receiving isatuximab for an indication other than RRMM

- Patients who have received any other investigational drug or prohibited therapy for

this study within 28 days or five half-lives from randomization, whichever is longer

- Patients having contraindication to the isatuximab summary of product characteristics

(SMPC) or package insert (PI)

- Patients having contraindications as noted in the drug-specific local isatuximab

SMPC/PI of combination drugs

- Any country-related specific regulation that would prevent the patient from entering

the study

The above information is not intended to contain all considerations relevant to a patient's

potential participation in a clinical trial.

Studien-Rationale

Primary outcome:

1. Overall response rate (ORR) (Time Frame - 12 months):
The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria

2. Progression free survival (PFS) (Time Frame - up to 18 months):
Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first.

3. Progression free survival rate (PFSR) (Time Frame - up to 18 months):
The proportion of patients who do not progress and are alive at specific time intervals

4. Duration of response (DoR) (Time Frame - 12 months):
Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR , VGPR , CR , or sCR to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first.

5. Time to response (TTR) (Time Frame - 12 months):
Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria

6. Time to first subsequent anti-myeloma therapy (Time Frame - 30 months):
Time from the initiation of isatuximab until the start of subsequent therapy or death.

7. Rate of very good partial response or better (Time Frame - up to 12 months):
Comprising VGPR, CR, and sCR within 12 months

8. Rate of complete response (CR) or better (Time Frame - up to 12 months):
Comprising CR and sCR responses within 12 months

9. Number of Participants with Adverse events (Time Frame - 1 month after end of treatment):
Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion

10. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30) (Time Frame - through end of treatment (up to approximately 2 years)):
The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact.

11. Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20) (Time Frame - through end of treatment (up to approximately 2 years)):
The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item).

Geprüfte Regime

  • isatuximab SAR650984 (Sarclisa):
    Pharmaceutical form: solution for infusion Route of administration: intravenous
  • Pomalidomide (Pomalyst):
    Pharmaceutical form: oral
  • Dexamethasone:
    Pharmaceutical form: oral
  • Carfilzomib:
    Pharmaceutical form: solution for infusion

Quelle: ClinicalTrials.gov


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