Trials / Completed
CompletedNCT02499081
UARK 2014-14: Phase II Prospective Evaluation of Bone Remodeling During Ixazomib Treatment
Phase II Prospective Evaluation of Bone Remodeling During Ixazomib Treatment Relapsed/Refractory Multiple Myeloma Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Arkansas · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effect of Ixazomib on inducing osteoblast activation as measured by bone markers and imaging in patients with relapsed/refractory myeloma.
Detailed description
This is a phase II study designed to examine the bone anabolic effect of the next generation proteasome inhibitor, ixazomib, in relapsed/refractory myeloma patients. Treatment consists of Ixazomib 4 mg on days 1, 8, 15, 22 of a 28 day cycle, for a maximum of 6 cycles. Determination of relapsed/refractory disease as an entry criterion may be based on patient data obtained during or following the patient's most recent prior antineoplastic therapy. Treatment periods will be defined as 28-day cycles. Patients will be seen at regular intervals while they are participating in the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ixazomib |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2018-05-17
- Completion
- 2018-05-17
- First posted
- 2015-07-15
- Last updated
- 2021-06-11
- Results posted
- 2021-05-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02499081. Inclusion in this directory is not an endorsement.