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NCT01365559 · ClinicalTrials.gov registry record · Phase 1
Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments
A Phase 1 study, sponsored by Oncotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01365559 is a Phase 1 study that has completed, run by Oncotherapeutics. The registered enrollment target is 39 participants.
The verdict
NCT01365559, a Phase 1 study, has completed, sponsored by Oncotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the same bortezomib-containing combination regimen to which a MM patient has progressed while receiving. This study will enroll 45 patients total. These patients will be resistant to bortezomib as demonstrated by progressive disease while on bortezomib or have relapsed within 12 weeks of the last dose of bortezomib in a combination regimen. Patients will be sub-divided into 2 groups in this study, treatments containing (Group A) or not containing immunomodulatory drugs (IMiDs) (Group B). Thirty patient will be enrolled into Group A and 15 patients into Group B for a total of 45 patients. Patients must have received 4 doses of a minimum of 1.0 mg/m\^2 of bortezomib in no more than 4 weeks per cycle. Patients must have received at least one cycle meeting this definition and have shown progressive disease to be considered eligible. Patients who have been refractory to or relapsed within 12 weeks of the last dose of bortezomib in their most recent bortezomib-containing regimen that does not include either thalidomide or lenalidomide are eligible regardless of when patients received that regimen, as long as they meet the above criteria. Carfilzomib will subsequently replace bortezomib using the patient's most recent bortezomib-containing regimen to which the patient progressed while receiving. Patients will be eligible if they progressed from bortezomib with an alkylating agent (melphalan or cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin) and/or a glucocorticosteroid (prednisone, dexamethasone or medrol)and IMiD (thalidomide or lenalidomide). The study will consist of a screening period, followed by up to eight open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, a follow-up period and maintenance cycles
Interventions
- DRUG Group A: Carfilzomib & Non-IMiD Regimen
- DRUG Group B: Carfilzomib & IMiD containing regimen.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-05-02 |
| Est. Completion | 2016-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01365559
The ClinicalTrials.gov registry entry for NCT01365559 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 2 interventions - of which Group A: Carfilzomib & Non-IMiD Regimen is the first listed.
NCT01365559 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01365559 about?
NCT01365559 is a clinical study titled "Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments". This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the same bortezomib-containing combination regimen to which a MM patient has progressed while receiving. This study will ...
What is the current status of trial NCT01365559?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2011-05-02. Estimated completion is 2016-03-01.
What interventions are being tested in trial NCT01365559?
The interventions under investigation include: Group A: Carfilzomib & Non-IMiD Regimen (DRUG), Group B: Carfilzomib & IMiD containing regimen. (DRUG).
Who is sponsoring clinical trial NCT01365559?
This trial is sponsored by Oncotherapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
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