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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: Active Phase 1 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, sponsored by SWOG Cancer Research Network.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assess safety of elotuzumab in combination with bortezomib, lenalidomide and dexamethasone and select the optimal dose of elotuzumab for the Phase II portion from 10mg/kg on each cycle, to 5mg/kg on each cycle MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 1/6 participants. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 3 nausea or diarrhea despite anti-emetic and anti-diarrheal therapy; grade 3 hyperglycemia if symptoma
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2012-11 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What the registry record for NCT01668719 still lists
NCT01668719 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, above the 36-participant average among 5 other DS Stage I Plasma Cell Myeloma trials with a reported enrollment target (294% higher).
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 names 20 study sites across 4 states, led by 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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