Gossypol Acetic Acid With Lenalidomide and Dexamethasone in Treating Patients With Relapsed Symptomatic Multiple Myeloma
NCT02697344 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-12-28
Summary
This phase I trial studies the side effects and best dose of R-(-)-gossypol acetic acid when given together with lenalidomide and dexamethasone and to see how well it works in treating patients with multiple myeloma, also known as plasma cell myeloma, that has come back after a period of improvement or has gotten worse after treatment. R-(-)-gossypol acetic acid may stop the growth of cancer cells by recognizing certain proteins and stimulating programmed cell death. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as 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. Giving R-(-)-gossypol acetic acid with lenalidomide and dexamethasone may work better in treating patients with multiple myeloma.
Conditions
- Recurrent Plasma Cell Myeloma
Interventions
- DRUG
-
Given PO
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Given PO
- OTHER
-
Pharmacological Study
Correlative studies
- DRUG
-
R-(-)-Gossypol Acetic Acid
Given PO
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Sikander Ailawadhi, 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
- 2016-04-14
- Primary Completion
- 2018-10-26
- Completion
- 2023-12-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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