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NCT01402284 · ClinicalTrials.gov registry record · Phase 2
Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01402284: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01402284 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01402284, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
Background: \- Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is sometimes used to treat (alone or with other drugs) certain types of cancer, especially multiple myeloma. This combination of drugs has not been tested in people with multiple myeloma. Researchers want to see whether it is safe and effective for this group. Objectives: \- To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma. Eligibility: \- People at least 18 years of age who have multiple myeloma that has not been treated. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, a bone marrow sample, and molecular imaging studies. * Participants will have eight 28-day cycles of treatment. The combined study drugs will be given as tablets and injections. Those in the study will be monitored with frequent blood tests, bone marrow samples, and molecular imaging studies. In addition to current standard measures to determine clinical responses, molecular tests will be conducted to define evidence of minimal residual disease. * After the first four cycles of therapy, those who are eligible for a stem cell transplant will have stem cells collected and stored for use if the cancer returns. * After stem cell collection, participants will have the second four treatment cycles. -, If the disease has improved or is stable at the end of eight cycles, those in the study may have another 12 cycles of low-dose (maintenance) lenalidomide alone. * Participants will have regular follow-up visits after the end of the study chemotherapy.
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Carfilzomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-07-21 |
| Est. Completion | 2020-09-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01402284
The ClinicalTrials.gov registry entry for NCT01402284 describes a study currently listed as completed, 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 National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01402284 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01402284 about?
NCT01402284 is a clinical study titled "Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients". Background: \- Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is sometimes used to ...
What is the current status of trial NCT01402284?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2011-07-21. Estimated completion is 2020-09-24.
What interventions are being tested in trial NCT01402284?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT01402284?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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