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NCT03104270 · ClinicalTrials.gov registry record · Phase 2
Combination Study for High Risk Multiple Myeloma Patients
A Phase 2 study, sponsored by Oncotherapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03104270: Clinical Trial Phase 2 study, sponsored by Oncotherapeutics.
NCT03104270 is a Phase 2 study that was terminated before completion, run by Oncotherapeutics. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03104270, a Phase 2 study, was terminated before completion, sponsored by Oncotherapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Despite the recent introduction of novel anti-multiple myeloma (MM) agents, high risk MM remains with poor prognosis and a therapeutic challenge. Elotuzumab (ELO) is a humanized monoclonal antibody that recognizes CS1/CD139, a molecule highly expressed in MM cells. The ELO (10 mg/kg), lenalidomide (LEN) and dexamethasone (DEX) combination achieves high overall response rates (ORR) and long progression-free survival (PFS) for patients with relapsed/refractory disease (RR) MM and those with impaired renal function. However, its efficacy for MM patients with high risk characteristics is still unknown. Pomalidomide (POM) is a recently approved immunomodulatory agent (IMiD) that produces response rates for high-risk RRMM patients when used in combination with DEX and other agents, including the proteasome inhibitor (PI) bortezomib (BTZ). POM has also demonstrated activity for LEN refractory patients. Carfilzomib (CFZ) is a potent second generation PI that has shown to be efficacious for IMiD and BTZ refractory patients as well as high risk patients carrying cytogenetic abnormalities. In this study, we propose to evaluate efficacy and safety of ELO in combination with POM, DEX and CFZ for high-risk RRMM patients.
Primary Outcome
Occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria (If necessary re-define MTD via the number of dose-limiting toxicities (DLTs) per dose level, of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone for high risk RRMM patients (based on six patients lead-in cohort if necessary).
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Carfilzomib
- DRUG Elotuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2020-01-23 |
| Phase | Phase 2 |
Why NCT03104270 stopped before completion
NCT03104270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT03104270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03104270 about?
NCT03104270 is a clinical study titled "Combination Study for High Risk Multiple Myeloma Patients". Despite the recent introduction of novel anti-multiple myeloma (MM) agents, high risk MM remains with poor prognosis and a therapeutic challenge. Elotuzumab (ELO) is a humanized monoclonal antibody that recognizes CS1/CD139, a molecule highly expressed in MM cells. The ELO (10 mg/kg), lenalidomide (...
What is the current status of trial NCT03104270?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2017-03-13. Estimated completion is 2020-01-23.
What interventions are being tested in trial NCT03104270?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Carfilzomib (DRUG), Elotuzumab (DRUG).
Who is sponsoring clinical trial NCT03104270?
This trial is sponsored by Oncotherapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03104270's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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