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NCT03215030 · ClinicalTrials.gov registry record · Phase 1
A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 1
- Development phase
- 272
- Enrollment target
NCT03215030: Clinical Trial Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT03215030 is a Phase 1 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 272 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (353% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03215030, a Phase 1 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 272 participants
- Enrollment target
Study Summary
The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as
Interventions
- DRUG Dexamethasone
- DRUG Modakafusp alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2017-10-04 |
| Est. Completion | 2024-11-07 |
| Phase | Phase 1 |
Why NCT03215030 stopped before completion
NCT03215030 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (353% higher).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT03215030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03215030 about?
NCT03215030 is a clinical study titled "A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma". The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2...
What is the current status of trial NCT03215030?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 272 participants. The study started on 2017-10-04. Estimated completion is 2024-11-07.
What interventions are being tested in trial NCT03215030?
The interventions under investigation include: Dexamethasone (DRUG), Modakafusp alfa (DRUG).
Who is sponsoring clinical trial NCT03215030?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03215030's enrollment target sits among peer trials
272 149th of 2000 higher than 1,851 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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