SC versus IV isatuximab in combination with pomalidomide and dexamethasone in RRMM
- Conditions
- Cancer - Plasma cell myeloma recurrent
- Registration Number
- 2023-508869-32-00
- Lead Sponsor
- Sanofi-Aventis Recherche & Developpement
- Brief Summary
- Demonstrate the efficacy non-inferiority between isatuximab subcutaneous (SC) and
isatuximab intravenous (IV) in combination with pomalidomide and dexamethasone (Pd)
- Demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 217
-Participants with multiple myeloma who have received at least one prior line of anti- myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
-Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).
-Primary refractory multiple myeloma participants
-Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
-Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
-Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
-Prior therapy with pomalidomide
Participants with inadequate biological tests.
-Significant cardiac dysfunction
- Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
-Concomitant plasma cell leukemia
-Active primary amyloid light -chain amyloidosis
-Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) Overall response rate (ORR)
Observed concentration before dosing (Cthrough) at steady state Observed concentration before dosing (Cthrough) at steady state
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Overall survival (OS)
Time to first response (TT1R) Time to first response (TT1R)
Time to best response (TTBR) Time to best response (TTBR)
Progression free survival (PFS) Progression free survival (PFS)
Progression free survival 2 (PFS2) Progression free survival 2 (PFS2)
Duration of response (DOR) Duration of response (DOR)
Very Good Partial Response or better rate (VGPR Very Good Partial Response or better rate (VGPR
Observed concentration before dosing (Ctrough) Observed concentration before dosing (Ctrough)
Incidence rate of infusion-reactions Incidence rate of infusion-reactions
Percentage of participants satisfied or very satisfied with the injection method used to administer study medication Percentage of participants satisfied or very satisfied with the injection method used to administer study medication
Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)
Pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax) Pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)
PK parameter: Area under the plasma concentration time curve over the dosing period (AUC) PK parameter: Area under the plasma concentration time curve over the dosing period (AUC)
Successful injection rate Successful injection rate
Percentage of participants with anti-drug antibodies (ADA) against isatuximab Percentage of participants with anti-drug antibodies (ADA) against isatuximab
Participant expectation questionnaire-baseline (PEQ-BL) score Participant expectation questionnaire-baseline (PEQ-BL) score
Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score
Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score
Patient’s Assessment of Treatment (PAT) questionnaire score Patient’s Assessment of Treatment (PAT) questionnaire score
Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores
Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score
Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20) Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)
Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores
Number of participants with chromosomal abnormalities Number of participants with chromosomal abnormalities
Trial Locations
- Locations (52)
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
🇮🇹Meldola, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Azienda Ospedaliero Universitaria Delle Marche
🇮🇹Ancona, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
🇮🇹Bologna, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
🇮🇹Brescia, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
🇮🇹Naples, Italy
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
🇵🇱Wroclaw, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
🇵🇱Lublin, Poland
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