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NCT04036461 · ClinicalTrials.gov registry record · Phase 1
A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT04036461 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 47 participants.
The verdict
NCT04036461, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.
Interventions
- DRUG CC-99712
- DRUG BMS-986405
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2024-08-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04036461
The ClinicalTrials.gov registry entry for NCT04036461 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CC-99712 is the first listed.
NCT04036461 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04036461 about?
NCT04036461 is a clinical study titled "A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma". Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the...
What is the current status of trial NCT04036461?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2019-08-26. Estimated completion is 2024-08-19.
What interventions are being tested in trial NCT04036461?
The interventions under investigation include: CC-99712 (DRUG), BMS-986405 (DRUG).
Who is sponsoring clinical trial NCT04036461?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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