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NCT03634800 · ClinicalTrials.gov registry record · Phase 2
Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M)
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT03634800: Clinical Trial Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT03634800 is a Phase 2 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03634800, a Phase 2 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Eligible patients have multiple myeloma with measurable disease in the blood and a targetable soft tissue or bony lesion with radiotherapy. All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy, 6 Gy x 5 fractions, to a targetable lesion. Immunotherapy treatment starts with the first radiotherapy fraction. Nivolumab will be given every 2 weeks. Patients will have specified laboratory values measured bi-monthly and evaluated for response at 12 weeks as defined by International Myeloma Working Group Criteria. Patients will continue to receive their respective immunotherapy until disease progression or dose limiting toxicity is reached.
Primary Outcome
The primary aim is to estimate the overall response at 12 weeks using IMWG criteria. Per IMWG response criteria, Complete Response (CR) is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Very Good Partial Response (VGPR) is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h; P
Interventions
- RADIATION Radiation therapy
- DRUG Nivolumab 240mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-10-23 |
| Est. Completion | 2020-01-16 |
| Phase | Phase 2 |
Why NCT03634800 stopped before completion
NCT03634800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Radiation therapy is the first listed.
NCT03634800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03634800 about?
NCT03634800 is a clinical study titled "Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M)". Eligible patients have multiple myeloma with measurable disease in the blood and a targetable soft tissue or bony lesion with radiotherapy. All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy, 6 Gy x 5 fractions, to a targetable lesion. Immunotherapy treatment starts with ...
What is the current status of trial NCT03634800?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2018-10-23. Estimated completion is 2020-01-16.
What interventions are being tested in trial NCT03634800?
The interventions under investigation include: Radiation therapy (RADIATION), Nivolumab 240mg (DRUG).
Who is sponsoring clinical trial NCT03634800?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03634800's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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