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NCT01668719 · ClinicalTrials.gov registry record · Phase 1

S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma

A Phase 1 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, sponsored by SWOG Cancer Research Network.

Active
Registry status
Phase 1
Development phase
142
Enrollment target
20
Study locations

NCT01668719 is a Phase 1 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 142 participants, above the 36-participant average among 5 other DS Stage I Plasma Cell Myeloma trials with a reported enrollment target (294% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT01668719, a Phase 1 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
142 participants
Enrollment target
20
Study locations

Study Summary

This partially randomized phase I/II trial studies the side effects and best dose of elotuzumab and to see how well it works when given together with lenalidomide, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to block cancer growth.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Bortezomib
  • BIOLOGICAL Elotuzumab

Study Locations (20)

Connecticut

  • Smilow Cancer Hospital-Derby Care Center - Derby
  • Smilow Cancer Hospital Care Center-Fairfield - Fairfield
  • Medical Oncology and Hematology Group PC-Guilford - Guilford
  • Smilow Cancer Hospital Care Center at Saint Francis - Hartford
  • The Hospital of Central Connecticut - New Britain
  • Yale University - New Haven
  • Yale-New Haven Hospital North Haven Medical Center - North Haven
  • Smilow Cancer Hospital-Orange Care Center - Orange
  • Charlotte Hungerford Hospital Center for Cancer Care - Torrington

Alaska

  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

California

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • City of Hope Comprehensive Cancer Center - Duarte
  • Los Angeles County-USC Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2012-11
Est. Completion 2025-12
Phase Phase 1

Sponsor

SWOG Cancer Research Network

270 total trials

What the Registry Record Tells You About NCT01668719

The ClinicalTrials.gov registry entry for NCT01668719 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 36-participant average among 5 other DS Stage I Plasma Cell Myeloma trials with a reported enrollment target (294% higher). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with DS Stage I Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01668719 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Connecticut, Alaska, California.

Frequently Asked Questions

What is clinical trial NCT01668719 about?

NCT01668719 is a clinical study titled "S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma". This partially randomized phase I/II trial studies the side effects and best dose of elotuzumab and to see how well it works when given together with lenalidomide, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely to recur (come back), or spread ...

What is the current status of trial NCT01668719?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 142 participants. The study started on 2012-11. Estimated completion is 2025-12.

What conditions does trial NCT01668719 study?

This clinical trial studies the following conditions: DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma.

What interventions are being tested in trial NCT01668719?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG), Elotuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01668719?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01668719 being conducted?

This trial has 20 study locations across Alaska, Arkansas, California, Connecticut. 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

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