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Completed Phase 3 Interventional Results available

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

ClinicalTrials.gov ID: NCT01335399

Public ClinicalTrials.gov record NCT01335399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 9:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

Study identification

NCT ID
NCT01335399
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
748 participants

Conditions and interventions

Interventions

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 4, 2011 (Actual)
Primary completion
Oct 1, 2019 (Actual)
Completion
Sep 3, 2021 (Actual)
Last update posted
Sep 30, 2022

2011 – 2021

United States locations

U.S. sites
88
U.S. states
32
U.S. cities
73
Facility City State ZIP Site status
Local Institution - 1628 Birmingham Alabama 35243 —
Local Institution - 7619 Mobile Alabama 36604 —
Local Institution - 7618 Mobile Alabama 36608 —
Local Institution - 7617 Chandler Arizona 85224 —
Local Institution - 1644 Tucson Arizona 85715 —
Local Institution - 1618 Bakersfield California 93309 —
Local Institution - 1602 Berkeley California 94704 —
Local Institution - 1636 Corona California 92879 —
Local Institution - 1668 Corona California 92879 —
Local Institution - 1616 Greenbrae California 94904 —
Local Institution - 7609 Long Beach California 90813 —
Local Institution - 1660 Los Angeles California 90095 —
Local Institution - 1673 Orange California 92868 —
Local Institution - 1613 San Diego California 92123 —
Local Institution - 1621 New Haven Connecticut 06520 —
Local Institution - 1612 Washington D.C. District of Columbia 20010 —
Local Institution - 1682 Boca Raton Florida 33486 —
Local Institution - 1617 Brooksville Florida 34613 —
Local Institution - 1648 Fort Myers Florida 33916 —
Local Institution - 7613 Hollywood Florida 33021 —
Local Institution - 1623 Jacksonville Florida 32256 —
Local Institution - 1625 New Port Richey Florida 34652 —
Local Institution - 1649 St. Petersburg Florida 33705 —
Local Institution - 1611 West Palm Beach Florida 33401 —
Local Institution - 1630 Atlanta Georgia 30322 —
Local Institution - 1684 Honolulu Hawaii 96819 —
Local Institution - 1607 Chicago Illinois 19123 —
Local Institution - 1635 Chicago Illinois 60612 —
Local Institution - 1632 Maywood Illinois 60153 —
Local Institution - 7606 Peoria Illinois 61615 —
Local Institution - 7610 Skokie Illinois 60077 —
Local Institution - 1603 Urbana Illinois 61801 —
Local Institution - 7616 Bloomington Indiana 47403 —
Local Institution - 7620 Indianapolis Indiana 46237 —
Local Institution - 1669 Indianapolis Indiana 46260 —
Local Institution - 1656 Mishawaka Indiana 46545 —
Local Institution - 1633 Iowa City Iowa 52242 —
Local Institution - 1674 Lexington Kentucky 40503 —
Local Institution - 1683 Louisville Kentucky 40207 —
Local Institution - 1646 Lafayette Louisiana 70503 —
Local Institution - 7614 Marrero Louisiana 70072 —
Local Institution - 1626 New Orleans Louisiana 70121 —
Local Institution - 1652 Shreveport Louisiana 71103 —
Local Institution - 1676 Baltimore Maryland 21204 —
Local Institution - 1650 Baltimore Maryland 21237 —
Local Institution - 1619 Boston Massachusetts 02215 —
Local Institution - 1699 Boston Massachusetts 02215 —
Local Institution - 1604 Detroit Michigan 48202 —
Local Institution - 1667 Jefferson City Missouri 65101 —
Local Institution - 1651 Springfield Missouri 65804 —
Local Institution - 1645 St Louis Missouri 63110 —
Local Institution - 1637 Omaha Nebraska 68198-7680 —
Local Institution - 7621 Mineola New York 11501 —
Local Institution - 1615 New York New York 10019 —
Local Institution - 1671 Stony Brook New York 11794-8183 —
Local Institution - 7604 Goldsboro North Carolina 27534 —
Local Institution - 1610 Winston-Salem North Carolina 27103 —
Local Institution - 1608 Cleveland Ohio 44195 —
Local Institution - 1693 Cleveland Ohio 44195 —
Local Institution - 1638 Columbus Ohio 43210 —
Local Institution - 1664 Columbus Ohio 43219 —
Local Institution - 1690 Middletown Ohio 45042 —
Local Institution - 1655 Tulsa Oklahoma 74146 —
Local Institution - 7611 Langhorne Pennsylvania 19047 —
Local Institution - 1647 Pittsburgh Pennsylvania 15224 —
Local Institution - 1679 Pittsburgh Pennsylvania 15240 —
Local Institution - 1677 Sayre Pennsylvania 18840 —
Local Institution - 1629 Charleston South Carolina 29414 —
Local Institution - 7615 Charleston South Carolina 29425 —
Local Institution - 1624 Greenville South Carolina 29615 —
Local Institution - 7607 Sioux Falls South Dakota 57105 —
Local Institution - 1600 Knoxville Tennessee 37909 —
Local Institution - 7628 Memphis Tennessee 38120 —
Local Institution - 1627 Nashville Tennessee 37203 —
Local Institution - 1670 Nashville Tennessee 37232-5505 —
Local Institution - 1634 Corpus Christi Texas 78412 —
Local Institution - 7612 Dallas Texas 75246 —
Local Institution - 1643 Houston Texas 77030 —
Local Institution - 1686 Houston Texas 77030 —
Local Institution - 1642 Houston Texas 77090 —
Local Institution - 7623 Ogden Utah 84405 —
Local Institution - 1657 Fredericksburg Virginia 22408 —
Local Institution - 1640 Seattle Washington 98108 —
Local Institution - 1631 Seattle Washington 98109 —
Local Institution - 1601 Huntington West Virginia 25701 —
Gundersen Clinic, Ltd La Crosse Wisconsin 54601 —
Local Institution - 1663 Madison Wisconsin 53717 —
Local Institution - 1609 Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 147 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01335399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 30, 2022 · Synced Oct 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01335399 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →