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NCT04895410 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma
A Phase 1 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04895410 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 8 participants.
The verdict
NCT04895410, a Phase 1 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed. Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide. In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests and side effects.
Interventions
- DRUG Dexamethasone
- BIOLOGICAL Daratumumab
- DRUG Pomalidomide
- DRUG Carfilzomib
- BIOLOGICAL Lemzoparlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-01-17 |
| Est. Completion | 2022-06-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04895410
The ClinicalTrials.gov registry entry for NCT04895410 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT04895410 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04895410 about?
NCT04895410 is a clinical study titled "Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma". Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with o...
What is the current status of trial NCT04895410?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-01-17. Estimated completion is 2022-06-24.
What interventions are being tested in trial NCT04895410?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (BIOLOGICAL), Pomalidomide (DRUG), Carfilzomib (DRUG), Lemzoparlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04895410?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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