Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT04512235 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAmyloidosis

Trial Overview Read MoreRead more

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 treatment.
 

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

This is a systemic therapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

Caelum Biosciences, Inc.

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.

Recruiting Hospitals Read MoreRead more

Box Hill Hospital, Malignant Haematology
Box Hill
Ms Liz Arnold
liz.arnold@monash.edu
03 9094 9516

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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