Isatuximab in combination with novel agents in RRMM

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 147

Inclusion Criteria

- Participant must be 18 years of age inclusive or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Participants with relapsed or refractory MM who have received at least
3 prior lines of therapy for MM, including PIs and IMiDs or at least 2
prior lines if at least one of these lines consisted of 2 or more multiagent
regimens (eg, Induction regimen with autologous stem cell transplant
followed by maintenance)
- RRMM with measurable disease:
->Serum M protein =0.5 g/dL measured using serum protein
immunoelectrophoresis and/or
->Urine M protein =200 mg/24 hours measured using urine protein
immunoelectrophoresis and/or
->Serum free light chain (sFLC) MM without measurable M protein in
serum or urine per previous criteria (serum Ig free light chain =10
mg/dL and abnormal serum Ig kappa lambda free light chain ratio <0.26
or >1.65)
- Men or woman or childbearing potential should agree to use
contraception.
- Substudy 01, 02(Terminated), 03: Anti-CD38 therapy naïve or prior exposure to such
drugs without being refractory but with a wash out of at least 6 months
after the last dose. Refractory is defined as progressing within 60 days
of last dose of anti-CD38 targeting therapy
-Substudy 04: Anti-CD38 and anti-BCMA therapy prior exposed participants with RRMM.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98

Exclusion Criteria

Medical conditions:
- Primary systemic amyloid light chain amyloidosis, plasma cell
leukemia, monoclonal gammopathy of undetermined significance, or
smoldering myeloma
- Uncontrolled infection within 14 days prior to first study intervention administration.
- Clinically significant cardiac (including valvular) or vascular disease
within 3 months prior to first study intervention administration., eg, myocardial infarction,
unstable angina, coronary (eg, coronary artery bypass graft,
percutaneous coronary intervention) or peripheral artery
revascularization, left ventricular ejection fraction <40%, heart failure
New York Heart Association Classes III and IV, stroke, transient
ischemic attack, pulmonary embolism, other thromboembolic event, or
cardiac arrhythmia (Grade 3 or higher by NCI CTCAE Version 5.0)
- Known acquired immunodeficiency syndrome-related illness or known
human immunodeficiency virus (HIV) disease requiring antiviral
treatment or active hepatitis A
Uncontrolled or active hepatitis B virus (HBV) infection
- Active hepatitis C virus (HCV) infection
- Any of the following within 3 months prior to first study intervention administration: treatment
resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious
or inflammatory bowel disease
- Second malignancy other than basal cell or squamous cell carcinoma of
the skin or in situ carcinoma, unless they are successfully treated with
curative intent for more than 3 years before randomization
Prior concomitant therapy:
- Any anti-MM drug treatment within 14 days before randomization,
including dexamethasone
- Participants with a contraindication to treatment
- Vaccination with a live vaccine 4 weeks before the start of the study
Criteria diagnostic assessment:
- Hemoglobin <8 g/dL
- Platelets <50 × 109/L
- Absolute neutrophil count <1.5 × 109/L
- Creatinine clearance <30 mL/min
- Total bilirubin >1.5 × ULN, except for known Gilbert syndrome in which
direct bilirubin should be =2.5 × ULN
- Aspartate aminotransferase and/or alanine aminotransferase >3 × ULN
- Patients with grade 3 or 4 hypercalcemia
Substudy 01:
-> Malabsorption syndrome or any condition that can significantly
impact the absorption of pomalidomide
-Substudy02(terminated):History of resected/ablated basal or squamous cell carcinoma(SCC)of the skin or carcinoma in situ of the cervix, or other local tumors, even if considered cured by local treatment.Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior to the first dose of SAR439459. Prothrombin time or INR >1.5 × upper limit of normal (ULN).
- Substudy 03:
Current corneal epithelial disease except mild punctate keratopathy
Patients who have received prior therapy with belantamab mafodotin
-Substudy04:Central nervous system or leptomeningeal disease.
Medical history of seizure.Participants currently receiving hepatically metabolized narrow therapeutic index drugs (eg,digoxin, warfarin) if cannot be closely monitored.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Phase 1

Sanofi-Aventis Recherche & Developpement

Updated 6/24/2024