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Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary Amyloidosis

NCT03252600 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-01-25

No results posted yet for this study

Summary

This randomized phase II trial studies how well lenalidomide, dexamethasone, and eotuzumab with or without cyclophosphamide work in treating patients with primary amyloidosis that has come back after a period of improvement. Drugs used in chemotherapy, such as lenalidomide, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as eotuzumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide, dexamethasone, and eotuzumab with cyclophosphamide may work better in treating patients with primary amyloidosis.

Conditions

  • Recurrent Primary Amyloidosis

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Dexamethasone

Given IV

BIOLOGICAL

Elotuzumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lenalidomide

Given PO

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Multiple Myeloma Research Consortium

    collaborator NETWORK

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Jeffrey Zonder, M.D. · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-25
Primary Completion
2023-12-07
Completion
2023-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03252600 on ClinicalTrials.gov