Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01049945 · ClinicalTrials.gov registry record · Phase 1
Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT01049945: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01049945 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01049945, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving bendamustine hydrochloride together with lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride and lenalidomide when given together with dexamethasone and to see how well they work in treating patients with relapsed multiple myeloma.
Primary Outcome
The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment: * Grade 2 neuropathy with pain * Any grade 3 Non-Hematologic toxicity * Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or de
Interventions
- DRUG dexamethasone
- DRUG lenalidomide
- DRUG bendamustine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-09-16 |
| Phase | Phase 1 |
What the finished NCT01049945 record still lists
NCT01049945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which dexamethasone is the first listed.
NCT01049945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01049945 about?
NCT01049945 is a clinical study titled "Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma". RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells ...
What is the current status of trial NCT01049945?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2010-02. Estimated completion is 2015-09-16.
What interventions are being tested in trial NCT01049945?
The interventions under investigation include: dexamethasone (DRUG), lenalidomide (DRUG), bendamustine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01049945?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01049945's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia