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NCT01160484 · ClinicalTrials.gov registry record · Phase 2
Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by Oncotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 8
- Study locations
NCT01160484: Completed Phase 2 study of Multiple Myeloma, sponsored by Oncotherapeutics.
NCT01160484 is a Phase 2 study of Multiple Myeloma that has completed, run by Oncotherapeutics. The registered enrollment target is 40 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160484, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Oncotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a phase II, multicenter, open label, nonrandomized study to evaluate the efficacy and safety of lenalidomide at a dose of 10 mg/dose in combination with bortezomib at 1.0 mg/m2/dose, pegylated liposomal doxorubicin (PLD) at 4.0 mg/m2/dose, and intravenous (IV) dexamethasone at 40 mg/dose in adult patients with relapsed/refractory multiple myeloma (MM). The study consists of a screening period, followed by up to eight 28 day open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a follow-up period.
Primary Outcome
The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be
Conditions Studied
Interventions
- DRUG DVD-R
Study Locations (8)
California
- Comprehensive Blood and Cancer Center - Bakersfield
- Hematology-Oncology Medical Group of Fresno, Inc. - Fresno
- Loma Linda University - Loma Linda
- Santa Barbara Hematology Oncology - Santa Barbara
- James R. Berenson, M.D., Inc. - West Hollywood
New York
- Bassett Cancer Institute - Cooperstown
- Broome Oncology - Johnson City
Florida
- Watson Clinic, LLP, Center for Care and Research - Lakeland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT01160484 record still lists
NCT01160484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which DVD-R is the first listed.
NCT01160484 lists 8 locations in 3 states (California, New York, Florida).
Frequently Asked Questions
What is clinical trial NCT01160484 about?
NCT01160484 is a clinical study titled "Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma". This is a phase II, multicenter, open label, nonrandomized study to evaluate the efficacy and safety of lenalidomide at a dose of 10 mg/dose in combination with bortezomib at 1.0 mg/m2/dose, pegylated liposomal doxorubicin (PLD) at 4.0 mg/m2/dose, and intravenous (IV) dexamethasone at 40 mg/dose in ...
What is the current status of trial NCT01160484?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2009-09. Estimated completion is 2012-09.
What conditions does trial NCT01160484 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01160484?
The interventions under investigation include: DVD-R (DRUG).
Who is sponsoring clinical trial NCT01160484?
This trial is sponsored by Oncotherapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01160484 being conducted?
This trial has 8 study locations across California, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01160484's enrollment target sits among peer trials
40 289th of 438 higher than 135 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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