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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 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.

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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.

Conditions Studied

Multiple Myeloma

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

FieldValue
Enrollment Target 40 participants
Start Date 2009-09
Est. Completion 2012-09
Phase Phase 2

Sponsor

Oncotherapeutics

17 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01160484

The ClinicalTrials.gov registry entry for NCT01160484 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The listed sponsor is Oncotherapeutics, which has 17 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.