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

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04458831
Collaborator
(none)
1,200
Enrollment
84
Locations
66.4
Anticipated Duration (Months)
14.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months

To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice

To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice

To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)

To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)

Secondary Objective:

Not applicable

Condition or Disease Intervention/Treatment Phase

Detailed Description

Duration per participant is 2.5 years

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Actual Study Start Date :
Aug 13, 2020
Anticipated Primary Completion Date :
Feb 23, 2026
Anticipated Study Completion Date :
Feb 23, 2026

Arms and Interventions

Arm Intervention/Treatment
Cohort 1

Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria

Drug: isatuximab SAR650984
Pharmaceutical form: solution for infusion Route of administration: intravenous
Other Names:
  • Sarclisa

    • Drug: Pomalidomide
    Pharmaceutical form: oral
    Other Names:
  • Pomalyst

    • Drug: Dexamethasone
    Pharmaceutical form: oral

    Drug: Carfilzomib
    Pharmaceutical form: solution for infusion

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate (ORR) [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) [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) [up to 18 months]

      The proportion of patients who do not progress and are alive at specific time intervals

    4. Duration of response (DoR) [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) [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 [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 [up to 12 months]

      Comprising VGPR, CR, and sCR within 12 months

    8. Rate of complete response (CR) or better [up to 12 months]

      Comprising CR and sCR responses within 12 months

    9. Number of Participants with Adverse events [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) [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) [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 8400021 Little Rock Arkansas United States 72205
    2 Investigational Site Number 8400009 San Francisco California United States 94143
    3 Investigational Site Number 8400030 Fort Lauderdale Florida United States 33308
    4 Investigational Site Number 8400007 Jacksonville Florida United States 32204
    5 Investigational Site Number 8400023 Lakeland Florida United States 33805
    6 Investigational Site Number 8400025 Pembroke Pines Florida United States 33024
    7 Investigational Site Number 8400026 Saint Petersburg Florida United States 33709
    8 Investigational Site Number 8400019 Garden City Kansas United States 67846
    9 Investigational Site Number 8400031 Lewiston Maine United States 04240
    10 Investigational Site Number 8400010 Farmington Hills Michigan United States 48334
    11 Investigational Site Number 8400006 Bolivar Missouri United States 65613
    12 Investigational Site Number 8400016 Kansas City Missouri United States 64114
    13 Investigational Site Number 8400017 Freehold New Jersey United States 07728
    14 Investigational Site Number 8400024 Howell New Jersey United States 07731
    15 Investigational Site Number 8400018 Little Silver New Jersey United States 07739
    16 Investigational Site Number 8400028 Winston-Salem North Carolina United States 27103
    17 Investigational Site Number 8400015 Canton Ohio United States 44708
    18 Investigational Site Number 8400012 Massillon Ohio United States 44646
    19 Investigational Site Number 8400020 Charleston South Carolina United States 29414
    20 Investigational Site Number 8400011 Greenville South Carolina United States 29615
    21 Investigational Site Number 8400002 Watertown South Dakota United States 57201
    22 Investigational Site Number 8400013 Houston Texas United States 77030
    23 Investigational Site Number 8400004 The Woodlands Texas United States 77380
    24 Investigational site number 0400002 Steyr Austria 4400
    25 Investigational site number 0400003 Wien Austria 1220
    26 Investigational site number 5600002 Sint-Niklaas Belgium
    27 Investigational site number 2500007 Argenteuil France 95107
    28 Investigational site number 2500006 Chambéry France 73000
    29 Investigational site number 2500012 Essey-lès-Nancy France 54270
    30 Investigational site number 2500013 Lille France 59037
    31 Investigational site number 2500004 Montpellier France 34295
    32 Investigational Site Number 2500009 Pessac France 33604
    33 Investigational site number 2500008 Poitiers France 86000
    34 Investigational site number 2500010 Reims France 51100
    35 Investigational site number 2500001 Rouen France 76000
    36 Investigational site number 2500005 Saint-Priest-en-Jarez France 42270
    37 Investigational site number 2500003 Toulouse France 31059
    38 Investigational site number 2500011 Vannes France 56007
    39 Investigational Site Number 2760014 Aschaffenburg Germany 63739
    40 Investigational Site Number 2760016 Aschaffenburg Germany 63739
    41 Investigational Site Number 2760025 Bad Liebenwerda Germany 04924
    42 Investigational Site Number 2760017 Baden-Baden Germany 76532
    43 Investigational Site Number 2760020 Bamberg Germany 96052
    44 Investigational Site Number 2760018 Bayreuth Germany 95445
    45 Investigational Site Number 2760003 Berlin Germany 10117
    46 Investigational Site Number 2760009 Berlin Germany 10715
    47 Investigational Site Number 2760007 Donauwörth Germany 86609
    48 Investigational site number 2760001 Dortmund Germany 44263
    49 Investigational Site Number 2760002 Dresden Germany 01127
    50 Investigational Site Number 2760035 Dresden Germany 01307
    51 Investigational Site Number 2760010 Frankfurt Germany 60389
    52 Investigational Site Number 2760037 Frankfurt Germany 60596
    53 Investigational Site Number 2760015 Goslar Germany 38642
    54 Investigational Site Number 2760012 Hanover Germany 30449
    55 Investigational Site Number 2760013 Herrsching Am Ammersee Germany 82211
    56 Investigational Site Number 2760026 Kulmbach Germany 95326
    57 Investigational Site Number 2760008 Leipzig Germany 04289
    58 Investigational Site Number 2760011 Magdeburg Germany 39104
    59 Investigational Site Number 2760006 Muenchen Germany 81241
    60 Investigational Site Number 2760021 Oldenburg Germany 26121
    61 Investigational Site Number 2760036 Oldenburg Germany 26133
    62 Investigational Site Number 2760040 Stolberg Germany 52222
    63 Investigational Site Number 2760031 Weilheim Germany 82362
    64 Investigational Site Number 2760019 Würzburg Germany 97080
    65 Investigational Site Number 3800005 Bologna Italy 40138
    66 Investigational Site Number 3800001 Napoli Italy 80131
    67 Investigational Site Number 3800010 Treviso Italy
    68 Investigational Site Number 3920010 Fukuoka Japan 815-8555
    69 Investigational Site Number 3920002 Kamogawa Japan 296-8602
    70 Investigational Site Number 3920007 Kashiwa Japan 277-8567
    71 Investigational Site Number 3920004 Minato-Ku Japan 105-8470
    72 Investigational Site Number 3920005 Okayama Japan 701-1192
    73 Investigational Site Number 3920009 Osaka Japan 543-8555
    74 Investigational Site Number 3920012 Sapporo Japan 003-0006
    75 Investigational Site Number 3920008 Shibukawa Japan 377-0280
    76 Investigational Site Number 3920006 Shibuya Japan 150-8935
    77 Investigational Site Number 3920003 Sunto-gun Japan 411-8777
    78 Investigational Site Number 3920011 Suwa Japan 392-8510
    79 Investigational Site Number 3920001 Yamagata-shi Japan 990-9585
    80 Investigational Site Number 5820001 Dordrecht Netherlands 3318AT
    81 Investigational Site Number 8400001 Hato Rey Puerto Rico 00917
    82 Investigational Site Number 5760003 Baden Switzerland 5404
    83 Investigational Site Number 5760001 Bern Switzerland 3010
    84 Investigational Site Number 5760002 Zürich Switzerland 8063

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04458831
    Other Study ID Numbers:
    • OBS16577
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Dexamethasone
    Pomalidomide

    Study Results

    No Results Posted as of Aug 15, 2022