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Multiple MyelomaPhase 3NCT02076009

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 145 sites in 18 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 this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma. 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?
Daratumumab, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
569 participants
Where
145 sitesin 18 countries
Study dates
23 Jul 2014to 21 Nov 2024
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

  • Must have documented multiple myeloma and measurable disease
  • Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
  • Must have documented evidence of progressive disease as defined by the International Myeloma Working Group criteria on or after their last regimen
  • Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
  • If a participant has received subsequent anticancer therapy (salvage therapy), the participant must have a "wash-out period" defined as 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the planned start date of daratumumab monotherapy. The only exception is the emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4 days) before Daratumumab monotherapy

Who cannot join

  • Has received any of the following therapies: daratumumab or other anti-CD38 therapies
  • Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
  • Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
  • Has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease
  • History of malignancy (other than multiple myeloma) within 5 years before the first dose of daratumumab monotherapy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)

Trial locations and contacts

145 sites in 18 countries.

145 sites in 18 countries

United States23 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bethesda, Maryland

  • Study site

    Boston, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Columbia, Maryland

  • Study site

    Dallas, Texas

  • Study site

    Eugene, Oregon

  • Study site

    Fairfax, Virginia

  • Study site

    Gainesville, Florida

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Omaha, Nebraska

  • Study site

    Rochester, Minnesota

  • Study site

    Spartanburg, South Carolina

  • Study site

    West Palm Beach, Florida

Other trials in United States

Japan15 sites

  • Study site

    Hitachi

  • Study site

    Kanazawa

  • Study site

    Kobe

  • Study site

    Kurume

  • Study site

    Matsuyama

  • Study site

    Nagoya

  • Study site

    Narita

  • Study site

    Ohgaki

  • Study site

    Okayama

  • Study site

    Osaka

  • Study site

    Sendai

  • Study site

    Shibukawa

  • Study site

    Shibuya City

  • Study site

    Tachikawa

  • Study site

    Tokyo

Other trials in Japan

France12 sites

  • Study site

    Argenteuil

  • Study site

    Caen

  • Study site

    Lille

  • Study site

    Limoges

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Pierre-Bénite

  • Study site

    Rennes

  • Study site

    Toulouse

  • Study site

    Tours

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Germany11 sites

  • Study site

    Berlin

  • Study site

    Bonn

  • Study site

    Cologne

  • Study site

    Hamburg

  • Study site

    Hamm

  • Study site

    Heidelberg

  • Study site

    Jena

  • Study site

    Karlsruhe

  • Study site

    Koblenz

  • Study site

    Saarbrücken

  • Study site

    Villingen-Schwenningen

Other trials in Germany

Canada10 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Surrey, British Columbia

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Russia9 sites

  • Study site

    Dzerzhinsk

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Petrozavodsk

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Syktyvkar

  • Study site

    Yekaterinburg

Other trials in Russia

Poland8 sites

  • Study site

    Brzozów

  • Study site

    Chorzów

  • Study site

    Gdansk

  • Study site

    Legnica

  • Study site

    Lublin

  • Study site

    Poznan

  • Study site

    Słupsk

  • Study site

    Wroclawa

Other trials in Poland

Belgium7 sites

  • Study site

    Anderlecht

  • Study site

    Antwerp

  • Study site

    Edegem

  • Study site

    Ghent

  • Study site

    Kortrijk

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Israel7 sites

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Nahariya

  • Study site

    Netanya

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Spain7 sites

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    La Laguna (Santa Cruz de Tenerife)

  • Study site

    Madrid

  • Study site

    Pamplona

  • Study site

    Salamanca

  • Study site

    Seville

Other trials in Spain

Sweden7 sites

  • Study site

    Falun

  • Study site

    Gothenburg

  • Study site

    Helsingborg

  • Study site

    Huddinge

  • Study site

    Lund

  • Study site

    Stockholm

  • Study site

    Uppsala

Other trials in Sweden

United Kingdom7 sites

  • Study site

    Birmingham

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Oxford

  • Study site

    Southampton

  • Study site

    Surrey

  • Study site

    Wolverhampton

Other trials in United Kingdom

Australia6 sites

  • Study site

    Camperdown

  • Study site

    Geelong

  • Study site

    Heidelberg

  • Study site

    Malvern

  • Study site

    South Brisbane

  • Study site

    Southport

Other trials in Australia

Taiwan5 sites

  • Study site

    Changhua

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Rotterdam

  • Study site

    Utrecht

  • Study site

    Zwolle

Other trials in Netherlands

Denmark3 sites

  • Study site

    Copenhagen

  • Study site

    Odense

  • Study site

    Vejle

Other trials in Denmark

South Korea3 sites

  • Study site

    Gyeonggi-do

  • Study site

    Incheon

  • Study site

    Seoul

Other trials in South Korea

Greece1 site

  • Study site

    Athens Attica

Other trials in Greece

About this study

Official title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

Read the detailed description

This is a randomized (participants will be assigned by chance to study treatments), open-label (all participants and study personnel will know the identity of the study treatments), active-controlled (none of the study treatments are placebo), parallel-group (both treatment arms will run at the same time), multicenter study. In this study, daratumumab, lenalidomide, and low-dose dexamethasone (DRd) will be compared with lenalidomide and low dose dexamethasone (Rd) in participants with relapsed or refractory multiple myeloma. Participants will be randomized in a 1:1 ratio to receive either DRd or Rd. The study will include a Screening Phase, a Treatment Phase (involving treatment cycles of approximately 28 days in length), and a Follow-up Phase. The Treatment Phase will extend from the administration of the first dose of study medication until disease progression or unacceptable toxicity. Participants will also discontinue study treatment if: they become pregnant; have their dose held for more than 28 days (or if 3 consecutive planned doses of daratumumab are missed for reasons other than toxicity); or for safety reasons (for example, adverse event). The Follow-up Phase will begin at the end of treatment and will continue until death, loss to follow-up, consent withdrawal for study participation, or the final overall survival (OS) analysis, whichever occurs first. Eligible participants from Rd group who have had sponsor confirmed disease progression will be offered the option for treatment with daratumumab monotherapy (of 28 days cycle). The primary endpoint will be progression-free survival (PFS). Analysis of the primary endpoint was performed at a pre-specified point determined by PFS events with a clinical cutoff of March 7, 2016 when 169 events of death or progression had occurred. The end of study is anticipated at approximately 6 years after the last participant is randomized. Blood and urine samples will be obtained at time points during the study, together with bone marrow aspirates/biopsies and skeletal surveys. Participant safety will be assessed throughout the study.

Keywords
Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Daratumumab, Lenalidomide, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • DaratumumabDrug

    Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; and every 4 weeks for cycles 7 and onwards. Following amendment 8, participants receiving daratumumab IV have the option to switch to daratumumab subcutaneous (SC) 1800 mg/dose until documented progression, unacceptable toxicity, or the end of study on Day 1 of any cycle, at the discretion of the investigator.

  • LenalidomideDrug

    Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.

  • DexamethasoneDrug

    Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 18.5).

Study groups in NCT02076009
Study groupRoleWhat they receive
Daratumumab + lenalidomide + dexamethasoneExperimentalDuring each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.
Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone
Lenalidomide + dexamethasoneActive comparatorDuring each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.
Receives: Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS: duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD: defined as meeting any 1 of following criteria: Increase of greater than equal to (>=)25 percent(%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hours(h) urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24h; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to plasma cell (PC) proliferative disorder.

    Measured: From randomization to either disease progression or death whichever occurs first (up to 21 months)

Secondary outcomes (8)

  1. Time to Disease Progression (TTP)

    TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to plasma cell (PC) proliferative disorder.

    Measured: From randomization to disease progression (up to 21 months)

  2. Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better

    VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.

    Measured: From randomization to disease progression (up to 21 months)

  3. Percentage of Participants With Negative Minimal Residual Disease (MRD)

    Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry. The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^ minus (-) 4, 10^-5, 10^-6 threshold.

    Measured: From randomization to the date of first documented evidence of PD (up to 87.5 months)

  4. Overall Response Rate

    Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

    Measured: From randomization to disease progression (up to 21 months)

  5. Overall Survival (OS)

    Overall survival was measured from the date of randomization to the date of the participant's death.

    Measured: From randomization to date of death due to any cause (up to 87.5 months)

  6. Time to Response

    Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.

    Measured: From randomization up to first documented CR or PR (up to 21 months)

  7. Duration of Response (DOR)

    DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.

    Measured: From randomization to the date of first documented evidence of PD (up to 21 months)

  8. Time to Subsequent Anticancer Treatment

    Time to subsequent anticancer treatment was defined as the time from randomization to the start of subsequent anticancer treatment or death due to progressive disease (PD), whichever occurs first.

    Measured: From randomization to date of start of subsequent anticancer treatment or death due to PD, whichever occured first (up to 87.5 months)

Timeline

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

  1. First posted3 Mar 2014 (estimated)
  2. Study start23 Jul 2014
  3. Primary completion7 Mar 2016
  4. Study completion21 Nov 2024

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
569 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02076009
Sponsor's protocol ID
CR103663
Other IDs
54767414MMY3003, 2013-005525-23
Status last verified
Apr 2025
First submitted
27 Feb 2014
Last updated
1 May 2025
Data monitoring committee
Yes

Publications

  • Almansour SA, Alqudah MAY, Abuhelwa Z, Al-Shamsi HO, Alhuraiji A, Semreen MH, Bustanji Y, Alzoubi KH, Modi ND, Mckinnon RA, Sorich MJ, Hopkins AM, Abuhelwa AY. Antithrombotic utilization, adverse events, and associations with treatment outcomes in multiple myeloma: pooled analysis of three clinical trials. Ther Adv Med Oncol. 2024 Sep 2;16:17588359241275387. doi: 10.1177/17588359241275387. eCollection 2024.

    PubMed 39229471

  • Spencer A, Moreau P, Mateos MV, Goldschmidt H, Suzuki K, Levin MD, Sonneveld P, Orlowski RZ, Yoon SS, Usmani SZ, Weisel K, Reece D, Ahmadi T, Pei H, Mayo WG, Gai X, Carey J, Bartlett JB, Carson R, Dimopoulos MA. Daratumumab for patients with myeloma with early or late relapse after initial therapy: subgroup analysis of CASTOR and POLLUX. Blood Adv. 2024 Jan 23;8(2):388-398. doi: 10.1182/bloodadvances.2023010579.

    PubMed 38048391

  • Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Ahmadi T, Qin X, Garvin Mayo W, Gai X, Carey J, Carson R, Moreau P. Overall Survival With Daratumumab, Lenalidomide, and Dexamethasone in Previously Treated Multiple Myeloma (POLLUX): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2023 Mar 10;41(8):1590-1599. doi: 10.1200/JCO.22.00940. Epub 2023 Jan 4.

    PubMed 36599114

  • Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.

    PubMed 34289038

  • Plesner T, Dimopoulos MA, Oriol A, San-Miguel J, Bahlis NJ, Rabin N, Suzuki K, Yoon SS, Ben-Yehuda D, Cook G, Goldschmidt H, Grosicki S, Qin X, Fastenau J, Garvin W, Carson R, Renaud T, Gries KS. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial. Br J Haematol. 2021 Jul;194(1):132-139. doi: 10.1111/bjh.17435. Epub 2021 Apr 6.

    PubMed 33822368

  • Avet-Loiseau H, San-Miguel J, Casneuf T, Iida S, Lonial S, Usmani SZ, Spencer A, Moreau P, Plesner T, Weisel K, Ukropec J, Chiu C, Trivedi S, Amin H, Krevvata M, Ramaswami P, Qin X, Qi M, Sun S, Qi M, Kobos R, Bahlis NJ. Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR. J Clin Oncol. 2021 Apr 1;39(10):1139-1149. doi: 10.1200/JCO.20.01814. Epub 2021 Jan 29.

    PubMed 33513030

  • Mateos MV, Spencer A, Nooka AK, Pour L, Weisel K, Cavo M, Laubach JP, Cook G, Iida S, Benboubker L, Usmani SZ, Yoon SS, Bahlis NJ, Chiu C, Ukropec J, Schecter JM, Qin X, O'Rourke L, Dimopoulos MA. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies. Haematologica. 2020 Jan 31;105(2):468-477. doi: 10.3324/haematol.2019.217448. Print 2020.

    PubMed 31221782

  • Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751.

    PubMed 27705267

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 145 sites in 18 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 5 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 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Japan, France, Germany, Canada and 13 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 10 Feb 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?

Progression-free Survival (PFS) (time frame: From randomization to either disease progression or death whichever occurs first (up to 21 months)). 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 NCT02076009, which also lists 8 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 May 2025.

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