Image

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Recruiting
18 years of age
Both
Phase 1/2

Powered by AI

Overview

The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.

Description

Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, Investigator decision, or study termination by the Sponsor i.e., up to Aapproximately 28 months.

Eligibility

Inclusion Criteria:

  • Participant must be 18 years of age inclusive or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • 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, 06: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 6 months after the last dose. "Exposure" is defined as at least 2 cycles of therapy.
  • Substudies 02, 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-B cell maturation antigen (BCMA) therapy prior exposed participants with RRMM.
  • Substudy 05: Participants with RRMM with at least 2 cycles of prior exposure to anti-CD38 therapy. For participants to whom BCMA targeted therapy is available (ie, approved in their region and can be reimbursed), at least 2 cycles of prior exposure to a BCMA targeted agent is mandatory.

Exclusion Criteria:

  • 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 first study intervention administration.
  • Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone.
  • Participants with a contraindication to treatment.
  • Vaccination with a live vaccine 4 weeks before the start of the study.
  • Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
  • Hemoglobin <8 g/dL.
  • Platelets <50 × 10^9/L.
  • Absolute neutrophil count <1.5 × 10^9/L.
  • Creatinine clearance <30 mL/min/1.73m2.
  • 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.
        Substudy 02:
          -  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
        Substudy 04:
          -  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.
        Substudy 05:
        - Participant unable to swallow tablets
        Substudy 06:
          -  History of active autoimmune disorders
          -  History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
          -  Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD
          -  Prior allogenic hematopoietic stem cell transplant (allo-HSCT)
          -  Hemoglobin < 9g/dL
          -  Prior therapy with any anti-CD47 or anti signal regulatory protein alpha agent
        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.

Study details

Plasma Cell Myeloma Refractory

NCT04643002

Sanofi

1 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.