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RecruitingLast updated: 8 January 2024

This phase I/II trial has been designed to find the recommended dose of a targeted therapy drug and determine whether it is more effective than chemotherapy as treatment for multiple myelomaPhase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol

Clinical summary

Summary

Eligible patients will be randomised to receive isatuximab and dexamethasone, in addition to either SAR439459 (experimental arm) or pomalidomide (control arm). This trial will include a screening period of up to 28 days for participants treated in each arm. Patients will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, Investigator decision, or study termination by the Sponsor, whichever occurs first. Patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until confirmation of disease progression. For patients who discontinue study treatment with confirmed disease progression, follow-up visits will be done every 3 months (12 weeks) from the date of last IMP administration until death or final cutoff date, whichever comes first. Adverse events and survival status will be collected.

Conditions

This trial is treating patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Sanofi Aventis

Scientific Title

Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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