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MRDas a Possible Predictive Factor for Relapse in AL Amyloidosis


Title Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients with AL Amyloidosis
Therapeutic Area Amyloidosis
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Max Age 99 Years
Gender All
Contact Melissa Warner
617 636-5907
More Information https://clinicaltrials.gov/ct2/show/NCT02555969

Overview

This study will assess AL amyloidosis patients who achieve good responses to treatment for minimal residual disease (MRD). MRD is the small amount of disease that may still be present below the clinically detectable level even after good response to treatment. This study will see if there is a correlation between presence or absence of MRD and disease relapse.We will use three laboratory techniques on donated blood and bone marrow samples to determine if MRD is present for each patient. This protocol will help provide insight into ways that the disease changes and progresses. Minimal Residual Disease testing is likely an important next step in AL management

Study Details

Inclusion Criteria

  • Diagnosis of AL amyloidosis
  • Willing to donate bone marrow
  • Has just completed therapy for AL amyloidosis with good response (CR or VGPR) or has therapy planned

Exclusion Criteria

  • Does not have a diagnosis of AL amyloidosis
  • Not able to provide bone marrow sample from baseline (before start of treatment)
  • Not willing to donate bone marrow

Study Requirements

This study requires a one time donation of blood (no more than 30 mL) and up to 4 donations of bone marrow (15 mL each). Bone marrow donation will be required at baseline (before treatment has begun)and each year after achieving best response to therapy (for up to 3 years). All of these donations will be timed with procedures that are required as standard of care. Therefore, no extra procedures are required. Each donation will only required slight prolongation of the procedure to allow collection of the research sample. No other procedures are required as a part of this study.