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NCT05556616 · ClinicalTrials.gov registry record · Phase 1

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma

A Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Terminated
Registry status
Phase 1
Development phase
15
Enrollment target

NCT05556616: Clinical Trial Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT05556616 is a Phase 1 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05556616, a Phase 1 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.

TERMINATED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp alfa. 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. Participants will be given modakafusp alfa through a vein.

Primary Outcome

DLT was defined by national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to th

Interventions

  • DRUG Lenalidomide
  • DRUG Daratumumab
  • DRUG Carfilzomib
  • DRUG Bortezomib
  • DRUG Modakafusp alfa

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-01-12
Est. Completion 2024-06-04
Phase Phase 1

Why NCT05556616 stopped before completion

NCT05556616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 5 interventions - of which Lenalidomide is the first listed.

NCT05556616 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05556616 about?

NCT05556616 is a clinical study titled "A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma". The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp alfa. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harm...

What is the current status of trial NCT05556616?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2023-01-12. Estimated completion is 2024-06-04.

What interventions are being tested in trial NCT05556616?

The interventions under investigation include: Lenalidomide (DRUG), Daratumumab (DRUG), Carfilzomib (DRUG), Bortezomib (DRUG), Modakafusp alfa (DRUG).

Who is sponsoring clinical trial NCT05556616?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05556616's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 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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Source: ClinicalTrials.gov NCT05556616, the US trial registry maintained by the National Library of Medicine. NCT05556616 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.