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NCT02504359 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma
A Phase 1 study of Recurrent Plasma Cell Myeloma and Plasma Cell Leukemia, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT02504359: Completed Phase 1 study of Recurrent Plasma Cell Myeloma and Plasma Cell Leukemia, sponsored by OHSU Knight Cancer Institute.
NCT02504359 is a Phase 1 study of Recurrent Plasma Cell Myeloma and Plasma Cell Leukemia that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 11 participants, below the 50-participant average among 23 other Recurrent Plasma Cell Myeloma trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02504359, a Phase 1 study of Recurrent Plasma Cell Myeloma and Plasma Cell Leukemia, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase Ib trial studies the side effects of combination chemotherapy and donor stem cell transplant followed by ixazomib citrate maintenance therapy in treating patients with multiple myeloma that has returned after a period of improvement and is likely to recur (come back), or spread. Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving ixazomib citrate after the transplant may improve the overall treatment outcome without causing additional toxicities.
Primary Outcome
Time to event analysis will be conducted to estimate day 100 TRM and its confidence interval among those who receive carmustine, cytarabine, etoposide, melphalan (BEAM) allogeneic transplantation.
Conditions Studied
Interventions
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Carmustine
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- DRUG Ixazomib Citrate
Study Locations (2)
North Carolina
- Duke University Medical Center - Durham
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-07-20 |
| Est. Completion | 2020-09-09 |
| Phase | Phase 1 |
What the finished NCT02504359 record still lists
NCT02504359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 50-participant average among 23 other Recurrent Plasma Cell Myeloma trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Recurrent Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Etoposide is the first listed.
NCT02504359 reports a single indexed study location in North Carolina, Oregon.
Frequently Asked Questions
What is clinical trial NCT02504359 about?
NCT02504359 is a clinical study titled "Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma". This phase Ib trial studies the side effects of combination chemotherapy and donor stem cell transplant followed by ixazomib citrate maintenance therapy in treating patients with multiple myeloma that has returned after a period of improvement and is likely to recur (come back), or spread. Giving ch...
What is the current status of trial NCT02504359?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2015-07-20. Estimated completion is 2020-09-09.
What conditions does trial NCT02504359 study?
This clinical trial studies the following conditions: Recurrent Plasma Cell Myeloma, Plasma Cell Leukemia.
What interventions are being tested in trial NCT02504359?
The interventions under investigation include: Etoposide (DRUG), Cytarabine (DRUG), Carmustine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Ixazomib Citrate (DRUG).
Who is sponsoring clinical trial NCT02504359?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02504359 being conducted?
This trial has 2 study locations across North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Plasma Cell Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02504359's enrollment target sits among peer trials
11 19th of 23 higher than 5 of 23 other Recurrent Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Plasma Cell Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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