S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

  • STATUS
    Not Recruiting
  • End date
    Jul 31, 2025
  • participants needed
    39
  • sponsor
    Southwest Oncology Group
Updated on 16 June 2021
Investigator
Susan Eubanks, RN, BSN, OCN
Primary Contact
East Carolina University (2.5 mi away) Contact
+293 other location
diabetes
constipation
cancer
hypertension
diarrhea
remission
hysterectomy
stem cell transplantation
multiple myeloma
absolute neutrophil count
ejection fraction
monoclonal antibodies
antiretroviral
systemic therapy
measurable disease
growth factor
hba1c
nt-probnp
natriuretic
investigational drug
dexamethasone
neutrophil count
blood transfusion
curcumin
unstable angina pectoris
monoclonal protein
hemoglobin a1c
line of therapy
immunoglobulins
serum protein
systemic amyloidosis
congo red
nervous
purpura
valvular heart disease
lymphadenopathy
acquired immunodeficiency
uncontrolled hypertension
mass spectrometry
gastroparesis
isatuximab
gastric atony

Summary

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.

Description

PRIMARY OBJECTIVES:

I. To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response or better) of isatuximab in relapsed/refractory systemic light chain (AL) amyloidosis.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in the treatment of relapsed/refractory AL amyloidosis with isatuximab.

II. To evaluate time to hematologic response. III. To evaluate duration of response. IV. To evaluate progression-free survival (PFS). V. To evaluate overall survival (OS).

TERTIARY OBJECTIVES:

I. To evaluate efficacy of isatuximab in relapsed/refractory immunoglobulin amyloid light chain (AL) amyloidosis as measured by organ specific response rates (cardiac, renal, gastrointestinal [GI], liver, soft tissue, nerve), in the subset of patients that can be evaluated for organ response.

II. To evaluate time to organ response in the subset of patients that can be evaluated for organ response.

OUTLINE

Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 30 days and then every at least every 6 months for up to 4 years.

Details
Condition Gastrointestinal Hemorrhage, Lymphadenopathy, Constipation, Diarrhea, Macroglossia, Hepatomegaly, Nausea, Purpura, Primary Systemic Amyloidosis, Amorphous, Eosinophilic, and Acellular Deposit, Early Satiety, Recurrent Primary Amyloidosis, Refractory Primary Amyloidosis, Amorphous, Eosinophilic, and Acellular Deposit, Amorphous, Eosinophilic, and Acellular Deposit, Amorphous, Eosinophilic, and Acellular Deposit
Treatment laboratory biomarker analysis, Isatuximab
Clinical Study IdentifierNCT03499808
SponsorSouthwest Oncology Group
Last Modified on16 June 2021

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