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NCT01109004 · ClinicalTrials.gov registry record · Phase 3
Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 3
- Development phase
- 758
- Enrollment target
NCT01109004: Completed Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01109004 is a Phase 3 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 758 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01109004, a Phase 3 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 758 participants
- Enrollment target
Study Summary
The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
Primary Outcome
Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.
Interventions
- DRUG Lenalidomide
- DRUG lenalidomide, bortezomib and dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 758 participants |
| Start Date | 2010-05 |
| Est. Completion | 2018-03-03 |
| Phase | Phase 3 |
What the finished NCT01109004 record still lists
NCT01109004 is an interventional study that assigns participants to a tested intervention. The registered 758 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Lenalidomide is the first listed.
NCT01109004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01109004 about?
NCT01109004 is a clinical study titled "Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)". The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous ...
What is the current status of trial NCT01109004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 758 participants. The study started on 2010-05. Estimated completion is 2018-03-03.
What interventions are being tested in trial NCT01109004?
The interventions under investigation include: Lenalidomide (DRUG), lenalidomide, bortezomib and dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01109004?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01109004's enrollment target sits among peer trials
758 456th of 2000 higher than 1,545 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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