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LymphomaPhase 3ELOQUENT - 2NCT01239797

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing Lenalidomide, Dexamethasone and Dexamethasone (Oral) in people with Lymphoma and Multiple Myeloma, run by Bristol-Myers Squibb at 216 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Multiple Myeloma
What is being tested?
Lenalidomide, Dexamethasone and Dexamethasone (Oral)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
646 participants
Where
216 sitesin 23 countries
Study dates
20 Jun 2011to 21 Apr 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented progression from most recent line of therapy
  • 1-3 prior lines of therapy
  • Measurable disease
  • Life expectancy ≥3 months
  • Prior treatment with Lenalidomide permitted if:
  • Best response achieved was ≥Partial Response (PR)
Show all 9Show fewer
  • Patient was not refractory
  • Patient did not discontinue due to a Grade ≥3 related adverse event
  • Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Who cannot join

  • Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
  • Active plasma cell leukemia
  • Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Trial locations and contacts

216 sites in 23 countries.

216 sites in 23 countries

United States63 sites

  • Winship Cancer Institute.

    Atlanta, Georgia, 30322

  • Georgia Health Science University

    Augusta, Georgia, 30912

  • Local Institution

    Berkeley, California, 94704

  • Local Institution

    Bethlehem, Pennsylvania, 18015

  • Local Institution

    Bismarck, North Dakota, 58501

  • Local Institution

    Boca Raton, Florida, 33486

  • Dana Farber Cancer Inst

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Cancer Care Centers Of Florida

    Brooksville, Florida, 34613

  • Local Institution

    Burbank, California, 91505

  • Local Institution

    Charleston, South Carolina, 29414

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Compassionate Cancer Res Grp

    Corona, California, 92879

  • Local Institution

    Corona, California, 92879

  • Cancer Specialists Of South Texas, Pa

    Corpus Christi, Texas, 78412

  • Ut Southwestern Medical Center

    Dallas, Texas, 75390-8565

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • San Diego Pacific Oncology& Hematology Associates, Inc

    Encinitas, California, 92024

  • Hematology-Oncology Associates Of Fredricksburg, Inc

    Fredericksburg, Virginia, 22408

  • Gaston Hematology & Oncology

    Gastonia, North Carolina, 28054

  • Local Institution

    Greenbrae, California, 94904

  • Local Institution

    Greenville, South Carolina, 29615

  • University Of Texas Md Anderson Cancer Ctr

    Houston, Texas, 77030

  • Northwest Cancer Center

    Houston, Texas, 77090

  • Local Institution

    Indianapolis, Indiana, 46260

  • Local Institution

    Iowa City, Iowa, 52242

  • Capitol Comprehensive Cancer Care Center

    Jefferson City, Missouri, 65101

  • Local Institution

    Knoxville, Tennessee, 37909

  • Gundersen Clinic, Ltd

    La Crosse, Wisconsin, 54601

  • Cancer Center Of Acadiana At Lafayette General

    Lafayette, Louisiana, 70503

  • Local Institution

    Las Vegas, Nevada, 89106

  • Local Institution

    Lexington, Kentucky, 40503

  • Ucla-Division Of Hematology/Oncology

    Los Angeles, California, 90095

  • Local Institution

    Louisville, Kentucky, 40207

  • University Of Wisconsin Hospital And Clinics

    Madison, Wisconsin, 53792

  • The West Clinic

    Memphis, Tennessee, 38120

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Local Institution

    Mishawaka, Indiana, 46545

  • Northwest Alabama Cancer Center, Pc

    Muscle Shoals, Alabama, 35661

  • Local Institution

    New Port Richey, Florida, 34652

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • Local Institution

    New York, New York, 10019

  • Weill Cornell Medical College

    New York, New York, 10065

  • University Of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Medical Oncology Care Associates

    Orange, California, 92868

  • Cancer Institute Of Florida

    Orlando, Florida, 32804

  • Pikeville Medical Center

    Pikeville, Kentucky, 41501

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Va Puget Sound Health Care System

    Seattle, Washington, 98108

  • Local Institution

    Shreveport, Louisiana, 71101

  • Local Institution

    Shreveport, Louisiana, 71103

  • Willis Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Local Institution

    Springfield, Missouri, 65807

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • Local Institution

    Stony Brook, New York, 11794-8151

  • Local Institution

    Titusville, Florida, 32796

  • Acrc/Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85715

  • Local Institution

    Tulsa, Oklahoma, 74136

  • Local Institution

    Vallejo, California, 94589

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

Other trials in United States

Germany21 sites

  • Local Institution

    Aschaffenburg, 63739

  • Local Institution

    Berlin, 12200

  • Local Institution

    Berlin, 13125

  • Local Institution

    Chemnitz, 09113

  • Local Institution

    Cologne, 50937

  • Local Institution

    Dresden, 01307

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Hamburg, 22763

  • Local Institution

    Hamburg, 66421

  • Local Institution

    Hamm, 59071

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Jena, 07747

  • Local Institution

    Kiel, 24105

  • Local Institution

    Marburg, 35037

  • Local Institution

    München, 81377

  • Local Institution

    München, 81675

  • Local Institution

    Münster, 48149

  • Local Institution

    Ravensburg, 88212

  • Local Institution

    Tübingen, 72076

  • Local Institution

    Ulm, 89081

  • Local Institution

    Würzburg, 97080

Other trials in Germany

Japan18 sites

  • Local Institution

    Bunkyo-Ku, Tokyo, 1138677

  • Local Institution

    Chiba, 260-8677

  • Local Institution

    Fukuoka, 812-8582

  • Local Institution

    Kamogawa, Toyko, 296-8602

  • Local Institution

    Koto-ku, Tokyo, 1358550

  • Local Institution

    Kyoto, 602-8566

  • Local Institution

    Maebashi, Gunma, 371-8511

  • Local Institution

    Nagoya, Aichi-ken, 4600001

  • Local Institution

    Nagoya, Aichi-ken, 4678602

  • Local Institution

    Niigata, 9518566

  • Local Institution

    Okayama, 7011192

  • Local Institution

    Osaka, Osaka, 5438555

  • Local Institution

    Sapporo, Hokkaido, 0608543

  • Local Institution

    Sendai, Miyagi, 980-8754

  • Local Institution

    Shibukawa-shi, Gunma, 3770280

  • Local Institution

    Shibuya-ku, Tokyo, 1508935

  • Local Institution

    Shinjuuku-ku, Tokyo, 1608582

  • Local Institution

    Toyohashi, 4418570

Other trials in Japan

France14 sites

  • Local Institution

    Blois, 41016

  • Local Institution

    Bordeaux, 33076

  • Local Institution

    Caen, 14000

  • Local Institution

    Clamart, 92140

  • Local Institution

    La Roche-sur-Yon, 85925

  • Local Institution

    La Tronche, 38700

  • Local Institution

    Lille, 59037

  • Local Institution

    Limoges, 87042

  • Local Institution

    Nantes, 44093

  • Local Institution

    Paris, 75012

  • Local Institution

    Pierre Benita, 69495

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Tours, 37044

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy13 sites

  • Local Institution

    Ancona, 60126

  • Local Institution

    Bergamo, 24127

  • Local Institution

    Bologna, 40138

  • Local Institution

    Florence, 50134

  • Local Institution

    Genova, 16132

  • Local Institution

    Meldola, 47014

  • Local Institution

    Milan, 20133

  • Local Institution

    Palermo, 90146

  • Local Institution

    Ravenna, 48100

  • Local Institution

    Rimini, 47923

  • Local Institution

    Roma, 00161

  • Local Institution

    Roma, 00168

  • Local Institution

    Torino, 10126

Other trials in Italy

Canada9 sites

  • Local Institution

    Barrie, L4M 6M2

  • Local Institution

    Calgary, Alberta, T2N 4N2

  • Local Institution

    Edmonton, Alberta, T6G 1Z2

  • Local Institution

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution

    London, Ontario, N6A 4G5

  • Local Institution

    Montreal, Quebec, H4J 1C5

  • Local Institution

    Montreal, H4A 3J1

  • Local Institution

    Saskatoon, Saskatchewan, S7N 4H4

  • Local Institution

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United Kingdom9 sites

  • Local Institution

    Airdrie, Lancashire, ML6 OJS

  • Local Institution

    Edinburgh, Midlothian, EH4 2XU

  • Local Institution

    Leeds, LS9 7FT

  • Local Institution

    London, Greater London, EC1A 7BE

  • Local Institution

    London, NW1 2PG

  • Local Institution

    Manchester, Greater Manchester, M20 4BX

  • Local Institution

    Newcastle upon Tyne, NE7 7DN

  • Local Institution

    Nottingham, Nottinghamshire, NG5 1PB

  • Local Institution

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Australia8 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Albury, New South Wales, 2640

  • Local Institution

    Canberra, New South Wales, 2605

  • Local Institution

    Malvern, Victoria, 3144

  • Local Institution

    Melbourne, Victoria, 3004

  • Local Institution

    Murdoch, 6150

  • Local Institution

    Nedlands, Western Australia, 6009

  • Local Institution

    South Brisbane, Queensland, 4101

Other trials in Australia

Belgium8 sites

  • Local Institution

    Antwerp, 2060

  • Local Institution

    Brussels, 1000

  • Local Institution

    Brussels, 1020

  • Local Institution

    Brussels, 1090

  • Local Institution

    Brussles, 1200

  • Local Institution

    Edegem-antwerp, 2650

  • Local Institution

    Liège, 4000

  • Local Institution

    Yvoir, 5530

Other trials in Belgium

Poland8 sites

  • Local Institution

    Bialystok, 15-276

  • Local Institution

    Chorzów, 41-500

  • Local Institution

    Lublin, 20-081

  • Local Institution

    Poznan, 60-569

  • Local Institution

    Warsaw, 02-106

  • Local Institution

    Warsaw, 02-507

  • Local Institution

    Warsaw, 02-776

  • Local Institution

    Wroclaw, 50-367

Other trials in Poland

Spain7 sites

  • Local Institution

    Badalona-Barcelona, 08916

  • Local Institution

    Madrid, 28006

  • Local Institution

    Madrid, 28007

  • Local Institution

    Murcia, 30008

  • Local Institution

    Salamanca, 37007

  • Local Institution

    Santiago de Comp-coruna, 15706

  • Local Institution

    Toledo, 45004

Other trials in Spain

Israel5 sites

  • Local Institution

    Afula, 18101

  • Local Institution

    Jerusalem, 91120

  • Local Institution

    Petah Tikva, 49100

  • Local Institution

    Rehovot, 76100

  • Local Institution

    Tsrifin, 70300

Other trials in Israel

Austria4 sites

  • Local Institution

    Rankweil, 6830

  • Local Institution

    Steyr, 4400

  • Local Institution

    Vienna, 1220

  • Local Institution

    Wels, 4600

Other trials in Austria

Czechia4 sites

  • Local Institution

    Brno, 625 00

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Prague, 100 34

  • Local Institution

    Prague, 128 08

Other trials in Czechia

Hungary4 sites

  • Local Institution

    Budapest, 1125

  • Local Institution

    Debrecen, H-4032

  • Local Institution

    Győr, 9024

  • Local Institution

    Szeged, H-6725

Other trials in Hungary

Romania4 sites

  • Local Institution

    Brasov, 500152

  • Local Institution

    Brasov, 700106

  • Local Institution

    Bucaresti, 030171

  • Local Institution

    Bucharest, 22328

Other trials in Romania

Turkey (Türkiye)4 sites

  • Local Institution

    Ankara, 06620

  • Local Institution

    Istanbul, CAPA, 34390

  • Local Institution

    Izmir, Bornova, 35100

  • Local Institution

    Izmir, 35330

Other trials in Turkey (Türkiye)

Denmark3 sites

  • Local Institution

    Copenhagen, 2100

  • Local Institution

    Odense C, 5000

  • Local Institution

    Vejle, 7100

Other trials in Denmark

Greece3 sites

  • Local Institution

    Athens, 11528

  • Local Institution

    Ioannina, 45500

  • Local Institution

    Larissa, 41110

Other trials in Greece

Ireland2 sites

  • Local Institution

    Dublin, 7

  • Local Institution

    Tullamore

Other trials in Ireland

Puerto Rico2 sites

  • Local Institution

    Ponce, 00716

  • Local Institution

    San Juan, 00918

Other trials in Puerto Rico

Switzerland2 sites

  • Local Institution

    Bern, 3010

  • Local Institution

    Geneva, 1211

Other trials in Switzerland

United Arab Emirates1 site

  • Local Institution

    Leicester, LE1 5WW

Other trials in United Arab Emirates

About this study

Official title: Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)

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).

Being tested
Lenalidomide, Dexamethasone, Dexamethasone (Oral), Dexamethasone (IV), Elotuzumab (BMS-901608; HuLuc63)
Medical subject headings
Lymphoma, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid®

    Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

  • DexamethasoneDrug

    Also called Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

    Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

  • Dexamethasone (Oral)Drug

    Also called Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

    On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug.

    On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug

  • Dexamethasone (IV)Drug

    Also called Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®

    On weeks without Elotuzumab dosing: Not Applicable (N/A)

    On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug

  • Elotuzumab (BMS-901608; HuLuc63)Biological

    Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Study groups in NCT01239797
Study groupRoleWhat they receive
Lenalidomide + DexamethasoneActive comparatorNot described
Receives: Drug: Lenalidomide; Drug: Dexamethasone
Lenalidomide + Dexamethasone +ElotuzumabExperimentalNot described
Receives: Drug: Lenalidomide; Drug: Dexamethasone (Oral); Drug: Dexamethasone (IV); Biological: Elotuzumab (BMS-901608; HuLuc63)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Progression Free Survival (PFS)

    Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.

    Measured: From randomization up to 326 events (up to approximately 38 months)

  2. Objective Response Rate (ORR)

    Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.

    Measured: From randomization up to approximately 38 months

Secondary outcomes (3)

  1. Median Overall Survival (OS)

    Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)

    Measured: Randomization to the date of death from any cause (up to approximately 9 years)

  2. Change From Baseline of Mean Score Pain Severity (BPI-SF)

    The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

    Measured: From baseline up to approximately 38 months

  3. Change From Baseline of Mean Score Pain Interference (BPI-SF)

    The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

    Measured: From baseline up to approximately 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2010 (estimated)
  2. Study start20 Jun 2011
  3. Primary completion2 Sep 2014
  4. Study completion21 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239797
Sponsor's protocol ID
CA204-004
Other IDs
2010-020347-12
Acronym
ELOQUENT - 2
Status last verified
May 2022
First submitted
8 Nov 2010
Last updated
1 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.

    PubMed 30204239

  • Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.

    PubMed 28070715

  • Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Rollig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.

    PubMed 26035255

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide, Dexamethasone and Dexamethasone (Oral) in people with Lymphoma and Multiple Myeloma, run by Bristol-Myers Squibb at 216 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in United States, Germany, Japan, France, Italy and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Progression Free Survival (PFS) (time frame: From randomization up to 326 events (up to approximately 38 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239797, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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