Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
NCT01864018 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2025-07-24
Summary
This phase I/II trial studies the side effects and the best dose of cyclophosphamide when given together with ixazomib citrate and dexamethasone in treating patients with previously untreated symptomatic multiple myeloma or light chain amyloidosis. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, 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. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib citrate and dexamethasone may be a better treatment for multiple myeloma or light chain amyloidosis.
Conditions
- Amyloidosis
- Plasma Cell Myeloma
Interventions
- DRUG
-
Given PO
- DRUG
-
Given PO
- DRUG
-
Ixazomib Citrate
Given PO
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Pharmacological Study
Correlative studies
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Shaji Kumar, M.D. · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-08-20
- Primary Completion
- 2021-04-30
- Completion
- 2023-09-09
Countries
- United States
Study Locations
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