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NCT02103335 · ClinicalTrials.gov registry record · Phase 1
Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT02103335 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 38 participants.
The verdict
NCT02103335, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are: * Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory drug) that has been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of multiple myeloma. * Marizomib is an investigational drug being developed by Triphase that is being studied for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet been approved by health authorities, such as the FDA, for general use but have been approved for use in specific clinical studies. Marizomib inhibits a cellular machine called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome inhibitors have been shown to be effective in the treatment of multiple myeloma. * Dexamethasone is a corticosteroid drug that affects the immune system (an immunomodulatory drug) that has been approved by the FDA for the treatment of multiple myeloma. This is the first study to evaluate the three-drug combination of pomalidomide (POM), marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory multiple myeloma. The primary objective of this study is to determine the best drug dosing levels for this three-drug combination, including the highest safe doses and/or the recommended doses for future clinical studies of this drug combination. The secondary purposes of this study are to determine the safety of this drug combination and its effectiveness in treating relapsed or refractory multiple myeloma. The study will include examination of levels of all three drugs in the blood during various time points during treatment.
Interventions
- DRUG pomalidomide
- DRUG marizomib
- DRUG low-dose dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2014-06-05 |
| Est. Completion | 2016-11-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02103335
The ClinicalTrials.gov registry entry for NCT02103335 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 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 3 interventions - of which pomalidomide is the first listed.
NCT02103335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02103335 about?
NCT02103335 is a clinical study titled "Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma". This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are: * Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory drug) that has been approved b...
What is the current status of trial NCT02103335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2014-06-05. Estimated completion is 2016-11-30.
What interventions are being tested in trial NCT02103335?
The interventions under investigation include: pomalidomide (DRUG), marizomib (DRUG), low-dose dexamethasone (DRUG).
Who is sponsoring clinical trial NCT02103335?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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