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NCT02188368 · ClinicalTrials.gov registry record · Phase 2
Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients
A Phase 2 study, sponsored by Oncotherapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT02188368 is a Phase 2 study that was terminated before completion, run by Oncotherapeutics. The registered enrollment target is 45 participants.
The verdict
NCT02188368, a Phase 2 study, was terminated before completion, sponsored by Oncotherapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM). Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient
Interventions
- DRUG PLD
- DRUG Steroids
- DRUG POM
- DRUG CFZ
- DRUG BTZ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-07-07 |
| Est. Completion | 2020-10-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02188368
The ClinicalTrials.gov registry entry for NCT02188368 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 45 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 5 interventions - of which PLD is the first listed.
NCT02188368 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02188368 about?
NCT02188368 is a clinical study titled "Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients". The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose ...
What is the current status of trial NCT02188368?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2014-07-07. Estimated completion is 2020-10-23.
What interventions are being tested in trial NCT02188368?
The interventions under investigation include: PLD (DRUG), Steroids (DRUG), POM (DRUG), CFZ (DRUG), BTZ (DRUG).
Who is sponsoring clinical trial NCT02188368?
This trial is sponsored by Oncotherapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
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