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S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
NCT01668719 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01668719
The ClinicalTrials.gov registry entry for NCT01668719 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01668719 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Connecticut, Alaska, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01668719?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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