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AzTrials

Multiple MyelomaPhase 3ELOQUENT - 1NCT01335399

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

A Phase 3 study testing Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608; HuLuc63) in people with Multiple Myeloma, run by Bristol-Myers Squibb at 235 sites in 20 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
Multiple Myeloma
What is being tested?
Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608; HuLuc63)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
748 participants
Where
235 sitesin 20 countries
Study dates
4 Aug 2011to 3 Sep 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

  • Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
  • have not received any prior systemic anti-myeloma therapy AND
  • have measurable disease AND
  • are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Who cannot join

  • Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
  • Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Active plasma cell leukemia
  • Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Trial locations and contacts

235 sites in 20 countries.

235 sites in 20 countries

United States88 sites

  • Local Institution - 1630

    Atlanta, Georgia, 30322

  • Local Institution - 1618

    Bakersfield, California, 93309

  • Local Institution - 1676

    Baltimore, Maryland, 21204

  • Local Institution - 1650

    Baltimore, Maryland, 21237

  • Local Institution - 1602

    Berkeley, California, 94704

  • Local Institution - 1628

    Birmingham, Alabama, 35243

  • Local Institution - 7616

    Bloomington, Indiana, 47403

  • Local Institution - 1682

    Boca Raton, Florida, 33486

  • Local Institution - 1619

    Boston, Massachusetts, 02215

  • Local Institution - 1699

    Boston, Massachusetts, 02215

  • Local Institution - 1617

    Brooksville, Florida, 34613

  • Local Institution - 7617

    Chandler, Arizona, 85224

  • Local Institution - 1629

    Charleston, South Carolina, 29414

  • Local Institution - 7615

    Charleston, South Carolina, 29425

  • Local Institution - 1607

    Chicago, Illinois, 19123

  • Local Institution - 1635

    Chicago, Illinois, 60612

  • 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 - 1636

    Corona, California, 92879

  • Local Institution - 1668

    Corona, California, 92879

  • Local Institution - 1634

    Corpus Christi, Texas, 78412

  • Local Institution - 7612

    Dallas, Texas, 75246

  • Local Institution - 1604

    Detroit, Michigan, 48202

  • Local Institution - 1648

    Fort Myers, Florida, 33916

  • Local Institution - 1657

    Fredericksburg, Virginia, 22408

  • Local Institution - 7604

    Goldsboro, North Carolina, 27534

  • Local Institution - 1616

    Greenbrae, California, 94904

  • Local Institution - 1624

    Greenville, South Carolina, 29615

  • Local Institution - 7613

    Hollywood, Florida, 33021

  • Local Institution - 1684

    Honolulu, Hawaii, 96819

  • Local Institution - 1643

    Houston, Texas, 77030

  • Local Institution - 1686

    Houston, Texas, 77030

  • Local Institution - 1642

    Houston, Texas, 77090

  • Local Institution - 1601

    Huntington, West Virginia, 25701

  • Local Institution - 7620

    Indianapolis, Indiana, 46237

  • Local Institution - 1669

    Indianapolis, Indiana, 46260

  • Local Institution - 1633

    Iowa City, Iowa, 52242

  • Local Institution - 1623

    Jacksonville, Florida, 32256

  • Local Institution - 1667

    Jefferson City, Missouri, 65101

  • Local Institution - 1600

    Knoxville, Tennessee, 37909

  • Gundersen Clinic, Ltd

    La Crosse, Wisconsin, 54601

  • Local Institution - 1646

    Lafayette, Louisiana, 70503

  • Local Institution - 7611

    Langhorne, Pennsylvania, 19047

  • Local Institution - 1674

    Lexington, Kentucky, 40503

  • Local Institution - 7609

    Long Beach, California, 90813

  • Local Institution - 1660

    Los Angeles, California, 90095

  • Local Institution - 1683

    Louisville, Kentucky, 40207

  • Local Institution - 1663

    Madison, Wisconsin, 53717

  • Local Institution - 1609

    Madison, Wisconsin, 53792

  • Local Institution - 7614

    Marrero, Louisiana, 70072

  • Local Institution - 1632

    Maywood, Illinois, 60153

  • Local Institution - 7628

    Memphis, Tennessee, 38120

  • Local Institution - 1690

    Middletown, Ohio, 45042

  • Local Institution - 7621

    Mineola, New York, 11501

  • Local Institution - 1656

    Mishawaka, Indiana, 46545

  • Local Institution - 7619

    Mobile, Alabama, 36604

  • Local Institution - 7618

    Mobile, Alabama, 36608

  • Local Institution - 1627

    Nashville, Tennessee, 37203

  • Local Institution - 1670

    Nashville, Tennessee, 37232-5505

  • Local Institution - 1621

    New Haven, Connecticut, 06520

  • Local Institution - 1626

    New Orleans, Louisiana, 70121

  • Local Institution - 1625

    New Port Richey, Florida, 34652

  • Local Institution - 1615

    New York, New York, 10019

  • Local Institution - 7623

    Ogden, Utah, 84405

  • Local Institution - 1637

    Omaha, Nebraska, 68198-7680

  • Local Institution - 1673

    Orange, California, 92868

  • Local Institution - 7606

    Peoria, Illinois, 61615

  • Local Institution - 1647

    Pittsburgh, Pennsylvania, 15224

  • Local Institution - 1679

    Pittsburgh, Pennsylvania, 15240

  • Local Institution - 1613

    San Diego, California, 92123

  • Local Institution - 1677

    Sayre, Pennsylvania, 18840

  • Local Institution - 1640

    Seattle, Washington, 98108

  • Local Institution - 1631

    Seattle, Washington, 98109

  • Local Institution - 1652

    Shreveport, Louisiana, 71103

  • Local Institution - 7607

    Sioux Falls, South Dakota, 57105

  • Local Institution - 7610

    Skokie, Illinois, 60077

  • Local Institution - 1651

    Springfield, Missouri, 65804

  • Local Institution - 1645

    St Louis, Missouri, 63110

  • Local Institution - 1649

    St. Petersburg, Florida, 33705

  • Local Institution - 1671

    Stony Brook, New York, 11794-8183

  • Local Institution - 1644

    Tucson, Arizona, 85715

  • Local Institution - 1655

    Tulsa, Oklahoma, 74146

  • Local Institution - 1603

    Urbana, Illinois, 61801

  • Local Institution - 1612

    Washington D.C., District of Columbia, 20010

  • Local Institution - 1611

    West Palm Beach, Florida, 33401

  • Local Institution - 1610

    Winston-Salem, North Carolina, 27103

Other trials in United States

Italy21 sites

  • Local Institution - 5067

    Ancona, 60126

  • Local Institution - 5065

    Bari, 70124

  • Local Institution - 5053

    Bergamo, 24127

  • Local Institution - 5070

    Bologna, 40138

  • Local Institution - 5066

    Florence, 50134

  • Local Institution - 5050

    Genova, 16132

  • Local Institution - 5057

    Meldola, 47014

  • Local Institution - 5069

    Milan, 20132

  • Local Institution - 5075

    Milan, 20122

  • Local Institution - 5052

    Monza, 20052

  • Local Institution - 5062

    Naples, 80131

  • Local Institution - 5068

    Naples, 80131

  • Local Institution - 5055

    Palermo, 90146

  • Local Institution - 5063

    Ravenna, 48100

  • Local Institution - 5073

    Reggio Nell Emilia (RE), 42100

  • Local Institution - 5064

    Rimini, 47923

  • Local Institution - 5058

    Roma, 00144

  • Local Institution - 5054

    Roma, 00168

  • Local Institution - 5056

    Rome, 00161

  • Local Institution - 5072

    Terni, 05100

  • Local Institution - 5051

    Torino, 10126

Other trials in Italy

Germany15 sites

  • Local Institution - 4565

    Aschaffenburg, 63739

  • Local Institution - 4550

    Berlin, 12200

  • Local Institution - 4555

    Chemnitz, 09113

  • Local Institution - 4563

    Cologne, 50937

  • Local Institution - 4562

    Dresden, 01307

  • Local Institution - 4552

    Hamm, 59063

  • Local Institution - 4553

    Heidelberg, 69120

  • Local Institution - 4560

    Jena, 07747

  • Local Institution - 4554

    Mainz, 55101

  • Local Institution - 4561

    München, 81377

  • Local Institution - 4558

    Münster, 48149

  • Local Institution - 4551

    Offenbach, 63069

  • Local Institution - 4556

    Stuttgart, 70376

  • Local Institution - 4564

    Tübingen, 72076

  • Local Institution - 4559

    Ulm, 89081

Other trials in Germany

Australia13 sites

  • Local Institution - 3612

    Adelaide, South Australia, 5000

  • Local Institution - 3601

    Fitzroy, Victoria, 3065

  • Local Institution - 3602

    Frankston, Victoria, 3199

  • Local Institution - 3600

    Garran, Australian Capital Territory, 2605

  • Local Institution - 3603

    Heidelberg Melbourne, Victoria, 3084

  • Local Institution - 3609

    Herston, Queensland, 4029

  • Local Institution - 3608

    Milton, Queensland, 4064

  • Local Institution - 3605

    Murdoch, 6150

  • Local Institution - 3611

    Nedlands, 6009

  • Local Institution - 3607

    Waratah, New South Wales, 2298

  • Local Institution - 3610

    Westmead, New South Wales, 2145

  • Local Institution - 3604

    Wodonga, Victoria, 3690

  • Local Institution - 3606

    Woodville South, South Australia, 5001

Other trials in Australia

Poland12 sites

  • Local Institution - 5250

    Bialystok, 15-276

  • Local Institution - 5252

    Chorzów, 41-500

  • Local Institution - 5254

    Gdansk, 80-952

  • Local Institution - 7626

    Krakow, 31-531

  • Local Institution - 5258

    Lodz, 93-510

  • Local Institution - 5257

    Lublin, 20-081

  • Local Institution - 5259

    Poznan, 60-569

  • Local Institution - 5255

    Szczecin, 70-111

  • Local Institution - 5256

    Warsaw, 02-106

  • Local Institution - 5253

    Warsaw, 02-507

  • Local Institution - 5260

    Warsaw, 02-776

  • Local Institution - 5251

    Wroclaw, 50-367

Other trials in Poland

Spain12 sites

  • Local Institution - 5552

    Badalona-barcelona, 08916

  • Local Institution - 5559

    Barcelona, 08036

  • Local Institution - 5555

    Barcelona, 08041

  • Local Institution - 5557

    Donostia / San Sebastian, 20014

  • Local Institution - 5561

    La Laguna- Tenerife, 38320

  • Local Institution - 5553

    Madrid, 28006

  • Local Institution - 5551

    Madrid, 28007

  • Local Institution - 5560

    Madrid, 28034

  • Local Institution - 5554

    Madrid, 28041

  • Local Institution - 5558

    Pamplona, 31008

  • Local Institution - 5550

    Salamanca, 37007

  • Local Institution - 5556

    Toledo, 45004

Other trials in Spain

Canada10 sites

  • Local Institution - 2601

    Calgary, Alberta, T2N 4N2

  • Local Institution - 2600

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 2603

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution - 2610

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution - 2606

    London, Ontario, N6A 5W9

  • Local Institution - 2605

    Montreal, Quebec, H1T 2M4

  • Local Institution - 2607

    Montreal, Quebec, H3A 1A1

  • Local Institution - 2611

    Saint John, New Brunswick, E2L 4L2

  • Local Institution - 2612

    Toronto, Ontario, M5G 2M9

  • Local Institution - 2602

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Israel10 sites

  • Local Institution - 4950

    Afula, 1834111

  • Local Institution - 4956

    Ashkelon, 7830604

  • Local Institution - 4960

    Haifa, 3109601

  • Local Institution - 4958

    Jerusalem, 91031

  • Local Institution - 4951

    Jerusalem, 91120

  • Local Institution - 4959

    Kfar Saba, 4428164

  • Local Institution - 4954

    Nahariya, 2210001

  • Local Institution - 4952

    Petah Tikva, 4941492

  • Local Institution - 4957

    Tel Aviv, 64239

  • Local Institution - 4955

    Tsrifin, 70300

Other trials in Israel

Belgium9 sites

  • Local Institution - 4160

    Brussels, 1020

  • Local Institution - 4156

    Brussels, 1090

  • Local Institution - 4157

    Brussles, 1200

  • Local Institution - 4154

    Charleroi, 6000

  • Local Institution - 4159

    Haine-Saint-Paul, 7100

  • Local Institution - 4158

    Leuven, 3000

  • Local Institution - 4150

    Liège, 4000

  • Local Institution - 4153

    Roeselare, 8800

  • Local Institution - 4151

    Yvoir, 5530

Other trials in Belgium

Romania6 sites

  • Local Institution - 5356

    Brasov, 500152

  • Local Institution - 5350

    Bucaresti, 030171

  • Local Institution - 5355

    Bucharest, 020125

  • Local Institution - 5353

    Bucharest, 050098

  • Local Institution - 5352

    Bucharest, 22328

  • Local Institution - 5351

    Lasi, 700483

Other trials in Romania

United Kingdom6 sites

  • Local Institution - 5951

    Belfast, Antrim, BT9 7AB

  • Local Institution - 5953

    London, Greater London, SE5 9RS

  • Local Institution - 5950

    London, EC1A 7BE

  • Local Institution - 5954

    London, HA1 3UJ

  • Local Institution - 5952

    London, NW1 2PG

  • Local Institution - 5955

    London, NW3 2QG

Other trials in United Kingdom

Greece5 sites

  • Local Institution - 4653

    Athens, 11527

  • Local Institution - 4651

    Athens, 11528

  • Local Institution - 4650

    Ioannina, 45500

  • Local Institution - 4652

    Larissa, 41110

  • Local Institution - 4654

    Pátrai, 26504

Other trials in Greece

Hungary5 sites

  • Local Institution - 4751

    Budapest, 1097

  • Local Institution - 4754

    Budapest, 1122

  • Local Institution - 4750

    Debrecen, 4012

  • Local Institution - 4753

    Győr, 9024

  • Local Institution - 4752

    Szeged, 6720

Other trials in Hungary

Austria4 sites

  • Local Institution - 4052

    Fadingerstraße 1, 4020

  • Local Institution - 4051

    Innsbruck, 6020

  • Local Institution - 4054

    Rankweil, 6830

  • Local Institution - 4053

    Wels, 4600

Other trials in Austria

Switzerland4 sites

  • Local Institution - 5751

    Bern, 3010

  • Local Institution - 5750

    Sankt Gallen, 9007

  • Local Institution - 5753

    Zurich, 8028

  • Local Institution - 5752

    Zurich, 8091

Other trials in Switzerland

Turkey (Türkiye)4 sites

  • Local Institution - 5851

    Ankara, Dikimevi, 06620

  • Local Institution - 5856

    Gaziantep, 27310

  • Local Institution - 5853

    Izmir, Bornova, 35100

  • Local Institution - 5854

    Izmir, Inciralti, 35340

Other trials in Turkey (Türkiye)

Czechia3 sites

  • Local Institution - 4252

    Hradec Králové, 500 05

  • Local Institution - 4250

    Prague, 100 34

  • Local Institution - 4251

    Prague, 128 08

Other trials in Czechia

Ireland3 sites

  • Local Institution - 4852

    Dublin, 7

  • Local Institution - 4850

    Dublin, 8

  • Local Institution - 4851

    Galway, 0

Other trials in Ireland

Russia3 sites

  • Local Institution - 5450

    Saint Petersburg, 197022

  • Local Institution - 5452

    Saint Petersburg, 197022

  • Local Institution - 5453

    Samara, 443095

Other trials in Russia

Puerto Rico2 sites

  • Local Institution - 7600

    Ponce, 00716

  • Local Institution - 7602

    San Juan, 00918

Other trials in Puerto Rico

About this study

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

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, Elotuzumab (BMS-901608; HuLuc63)
Keywords
Newly Diagnosed, Previously Untreated
Medical subject headings
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

  • DexamethasoneDrug

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

    Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), 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, once daily, on Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

  • DexamethasoneDrug

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

    Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

  • Elotuzumab (BMS-901608; HuLuc63)Biological

    Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

  • Elotuzumab (BMS-901608; HuLuc63)Biological

    Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Study groups in NCT01335399
Study groupRoleWhat they receive
Lenalidomide + DexamethasoneActive comparatorNot described
Receives: Drug: Lenalidomide; Drug: Dexamethasone
Lenalidomide + Dexamethasone + ElotuzumabExperimentalNot described
Receives: Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608; HuLuc63)

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause.

    The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria.

    Censoring rules applied:

    • Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy.
    • Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event.
    • Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment.
    • Participants without any post-baseline tumor assessments were censored on the date of randomization

    Measured: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.

    Measured: From randomization to primary completion date (approximately 8 years)

  2. Overall Survival (OS)

    Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").

    Measured: From randomization to the date of death (up to 8 years)

  3. Mean Change From Baseline of Pain Severity Score and Pain Interference Score

    Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF).

    BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).

    Measured: From Baseline to End of Treatment (approximately 8 years)

  4. Progression Free Survival (PFS) Rate at Specific Time-points

    PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.

    Measured: From randomization to the specified time-point (up to 5 years)

Timeline

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

  1. First posted14 Apr 2011 (estimated)
  2. Study start4 Aug 2011
  3. Primary completion1 Oct 2019
  4. Study completion3 Sep 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
748 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01335399
Sponsor's protocol ID
CA204-006
Other IDs
2010-022445-20
Acronym
ELOQUENT - 1
Status last verified
Sep 2022
First submitted
13 Apr 2011
Last updated
30 Sep 2022
Data monitoring committee
Yes

Publications

  • Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.

    PubMed 35550060

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608; HuLuc63) in people with Multiple Myeloma, run by Bristol-Myers Squibb at 235 sites in 20 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 4 inclusion and 5 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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Italy, Germany, Australia, Poland and 15 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 22 Oct 2020). 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?

Progression-Free Survival (PFS) (time frame: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)). 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 NCT01335399, which also lists 1 linked publication.

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 30 Sep 2022.

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