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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 is a Phase 2 study that was terminated before completion, run by Oncotherapeutics. The registered enrollment target is 13 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03104270
The ClinicalTrials.gov registry entry for NCT03104270 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oncotherapeutics, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT03104270 reports 0 study locations.
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.
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