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RecruitingLast updated: 15 August 2023

This phase III study is trying to determine the effectiveness of targeted therapy (CAEL-101) combined with the Standard of Care treatment, compared to a placebo combined with the Standard of Care treatment, in people with Mayo stage IIIa AL amyloidosis that have not received prior treatmentA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis

Clinical summary

Summary

This is a randomised, double-blind trial with two arms. In the Experimental Arm, participants will receive CAEL-101, administered as an intravenous (IV) infusion and also receive Standard of Care plasma cell dyscrasia. In the Placebo Comparator Arm, participants will receive a placebo, administered via IV, and also receive Standard of Care plasma cell dyscrasia. The minimum planned treatment time for each participant is 50 weeks. The Standard of Care treatment for Plasma Cell Dyscrasia that all participants receives will consist of a cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen.

Conditions

This trial is treating patients with Mayo Stage IIIa AL Amyloidosis.

Cancer

Blood Cancers Blood

Age

People18+

Phase

III

More information

Trial Identifiers

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Commercial Sponsor

Caelum Biosciences, Inc.

Scientific Title

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis

Eligibility

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

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