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Multiple MyelomaPhase 2NCT03871829

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

A Phase 2 study testing Carfilzomib 20 mg/m^2, Carfilzomib 70 mg/m^2 and Dexamethasone 40 mg in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 108 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in… 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?
Carfilzomib 20 mg/m^2, Carfilzomib 70 mg/m^2 and Dexamethasone 40 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
108 sitesin 13 countries
Study dates
31 May 2019to 10 Jan 2023
Phase
Phase 2
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

  • Evidence of a response (partial response or better based on investigator's determination of response by International Myeloma Working Group [IMWG] criteria) to daratumumab-containing therapy with response duration of at least 4 months
  • Participants must have progressed from or be refractory to their last line of treatment. Relapsed or refractory disease as defined as: a) Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or >60 days after cessation of treatment
  • Received 1 to 3 prior line(s) of treatment of which one contained daratumumab, and completed daratumumab at least 3 months prior to randomization. A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram per day [mg/day] for 4 days) would not be considered prior lines of therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization

Who cannot join

  • Previous treatment with daratumumab within the last 3 months prior to randomization
  • Discontinuation of daratumumab due to a daratumumab-related adverse event (AE)
  • History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further 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 3 years
  • Allergies, hypersensitivity, or intolerance to daratumumab, hyaluronidase, monoclonal antibodies (mAbs), human proteins, or their excipients, or known sensitivity to mammalian-derived products. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
  • Participant is: a) Known to be seropositive for human immunodeficiency virus (HIV) with one or more of the following: not receiving highly active antiretroviral therapy (ART), had a change in ART within 6 months of the start of screening, receiving ART that may interfere with study treatment, cluster of differentiation (CD)4 count <350 (unit: cells per cubic millimeter of blood) at screening, acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of start of screening, and not agreeing to start ART and be on ART >4 weeks plus having HIV viral load <400 copies/milliliters (mL) at end of 4-week period (to ensure ART is tolerated and HIV controlled. b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (example: participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. c) Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)

Trial locations and contacts

108 sites in 13 countries.

108 sites in 13 countries

Italy18 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50139

  • IRCCS Azienda Ospedaliera San Martino - IST

    Genova, 16132

  • San Martino Hospital

    Genova, 16132

  • Asst Ovest Milanese - Ospedale Di Legnano

    Legnano, 20025

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale Maggiore della Carita

    Novara, 28100

  • Casa di Cura La Maddalena

    Palermo, 90146

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Universita Degli Studi di Roma Tor Vergata

    Roma, 00133

  • Sapienza University of Rome

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • ASL ROMA

    Roma, 30 - 00153

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliera Santa Maria

    Terni, 5100

Other trials in Italy

Brazil14 sites

  • Universidade Estadual De Campinas

    Campinas, 13083-878

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiânia, 74605-020

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20230-130

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001

  • Hospital Sao Rafael

    Salvador, 41253-190

  • CEHON

    Salvador, 45995-000

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, 01236-030

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01321-001

  • Clinica Sao Germano

    São Paulo, 01455 010

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

    São Paulo, 03102-002

Other trials in Brazil

France14 sites

  • Hopital Claude Huriez

    Lille, 59037

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295

  • Centre Hospitalier Emile Muller

    Mulhouse, 68100

  • Hotel Dieu

    Nantes, 44035

  • Hopitaux Universitaires Est Parisien Hopital Saint Antoine

    Paris, 75012

  • Hopital de la Pitie Salpetriere

    Paris, 75013

  • Hôpital Necker-Enfants Malades

    Paris, 75743

  • Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux

    Pessac, 33600

  • Centre Hospitalier Lyon-Sud Service d'hematologie

    Pierre-Bénite, 69310

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35033

  • Institut Claudius Regaud

    Toulouse, 31052

  • CHU Bretonneau

    Tours, 37044

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain14 sites

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. de Leon

    León, 24008

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. de La Paz

    Madrid, 28046

  • Hosp. Costa Del Sol

    Málaga, 29603

  • Hosp. Univ. Son Espases

    Palma, 7120

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Gral. Univ. de Toledo

    Toledo, 45007

Other trials in Spain

Germany12 sites

  • Universitaetsklinikum Koelnt

    Cologne, 50397

  • Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

    Dresden, 1307

  • Evangelisches Krankenhaus Essen-Werden

    Essen, 45239

  • Universitatsklinikum Essen

    Essen, D-45147

  • Universitatsklinik Hamburg Eppendorf UKE

    Hamburg, 20246

  • St. Barbara-Klinik Hamm GmbH

    Hamm, 59075

  • Praxisklinik für Haematologie und Onkologie Koblenz

    Koblenz, 56068

  • Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany

    Mainz, 55101

  • Onkologische Schwerpunkt Praxis

    Saarbrücken

  • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany

    Tübingen, 72076

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78052

  • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

    Würzburg, 97080

Other trials in Germany

United States11 sites

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • Baylor Scott and White Health

    Dallas, Texas, 75246

  • Karmanos Cancer Institute - Wayne State University

    Detroit, Michigan, 48201

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46804

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Millennium Oncology

    Houston, Texas, 77090

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Washington University School Of Medicine

    St Louis, Missouri, 63110-1032

  • Oncology Institute of Hope and Innovation

    Tucson, Arizona, 85745

  • American Institute of Research (AIR)

    Whittier, California, 90603

Other trials in United States

Russia7 sites

  • Emergency Hospital of Dzerzhinsk

    Dzerzhinsk, 606019

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126

  • Ryazan Regional Clinical Hospital

    Ryazan, 390003

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024

  • Oncological dispensary #2

    Sochi, 354057

  • Oncology Dispensary of Komi Republic

    Syktyvkar, 167904

Other trials in Russia

Greece5 sites

  • University of Athens - Evaggelismos Hospital (Evangelismos Hospital)

    Athens, 106 76

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28

  • University Hospital Of Larissa

    Larissa, 41110

  • University General Hospital of Rio

    Pátrai, 26500

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39

Other trials in Greece

Denmark4 sites

  • Aarhus University Hospital

    Aarhus N, DK-8200

  • Regionshospitalet i Holstebro

    Holstebro, 7500

  • Haematological Research unit HFE-X OUH.

    Odense, 5000

  • Vejle Hospital

    Vejle, DK-7100

Other trials in Denmark

Poland4 sites

  • Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Szpital Wojewodzki w Opolu

    Opole, 45-061

  • Szpital Magodent

    Warsaw, 01 748

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367

Other trials in Poland

Belgium2 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

Netherlands2 sites

  • Albert Schweitzer ziekenhuis-lokatie Dordwijk

    Dordrecht, 3318 AT

  • Zuyderland Medical Center

    Sittard, 6130 MB

Other trials in Netherlands

Canada1 site

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

Other trials in Canada

About this study

Official title: A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment

The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.

Read the detailed description

For relapsed or refractory multiple myeloma, the treatment is determined on an individual basis. Common standard of care regimens use either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD) in combination with dexamethasone with or without a monoclonal antibody (mAb) such as daratumumab. After relapse from PIs or IMiDs, patients are often retreated with drugs that have same mechanism of action to which they have been sensitive. The disease becomes refractory and all effective treatment options are exhausted. Daratumumab is a human IgG1 mAb that binds with high affinity to unique epitope on cluster of differentiation 38 (CD38) and attacks tumor cells that overexpress CD38. Study is to determine the efficacy of Dara-SC in combination with carfilzomib and dexamethasone (DKd) in adult participants with relapsed refractory MM who had 1 to 3 prior line(s) of treatment including a line containing daratumumab to evaluate daratumumab retreatment. The MM treatment is determined on an individual basis where patient's age, prior therapy, bone marrow function, co-morbidities, patient preference and time to relapse are considered. Common standard of care regimens use either PI or an IMiD in combination with dexamethasone with or without a mAb. It is a targeted immunotherapy that attacks tumor cells that overexpress CD38, a transmembrane glycoprotein, in a variety of hematological malignancies including multiple myeloma. The study will be conducted in 3 phases: Screening (28 days), Treatment, and Follow-Up. Assessments like chest X-ray, spirometry test, electrocardiogram (ECG), will be performed during Screening phase. During the Treatment Phase, participants will be randomized to receive Kd or DKd. Efficacy assessments like bone marrow examination will be performed. Follow-up will continue until the end of study.

Being tested
Carfilzomib 20 mg/m^2, Carfilzomib 70 mg/m^2, Dexamethasone 40 mg, Dara-SC 1800 mg, Dexamethasone 20 mg
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Carfilzomib 20 mg/m^2Drug

    Carfilzomib 20 mg/m^2 will be administered intravenously (IV).

  • Carfilzomib 70 mg/m^2Drug

    Carfilzomib 70 mg/m^2 will be administered IV.

  • Dexamethasone 40 mgDrug

    Dexamethasone 40 mg will be administered as IV infusion or orally.

  • Dara-SC 1800 mgDrug

    Dara-SC 1800 mg will be administered by SC injection.

  • Dexamethasone 20 mgDrug

    Dexamethasone 20 mg will be administered as IV infusion or orally.

Study groups in NCT03871829
Study groupRoleWhat they receive
Arm A: Carfilzomib+Dexamethasone (Kd)Active comparatorParticipants will receive carfilzomib 20 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 and then 70 mg/m^2 on Days 8 and 15 of Cycle 1 and thereafter on Days 1, 8, 15 of Cycle 2 onwards. Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study. The total duration of each cycle is 28 Days.
Receives: Drug: Carfilzomib 20 mg/m^2; Drug: Carfilzomib 70 mg/m^2; Drug: Dexamethasone 40 mg; Drug: Dexamethasone 20 mg
Arm B: Dara-SC in combination with Kd (DKd)ExperimentalParticipants will receive daratumumab subcutaneous (Dara-SC) 1800 mg by SC injection on Days 1, 8, 15, 22 for Cycle 1 and 2, Days 1 and 15 for Cycle 3-6, Day 1 for Cycle 7 onwards. Participants will receive carfilzomib 20 mg/m^2 IV on Cycle 1 Day 1 and then 70 mg/m^2 on Day 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2. Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study. The total duration of each cycle is 28 Days.
Receives: Drug: Carfilzomib 20 mg/m^2; Drug: Carfilzomib 70 mg/m^2; Drug: Dexamethasone 40 mg; Drug: Dara-SC 1800 mg; Drug: Dexamethasone 20 mg

What is being measured

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

  1. Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response

    Percentage of participants achieving VGPR or better response were reported. VGPR or better rate was defined as the percentage of participants achieving VGPR, complete response (CR), or stringent complete response (sCR) in accordance with the International Myeloma Working Group (IMWG) criteria, during or after the study treatment but before the start of subsequent anti-myeloma therapy. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein less than (<) 100 milligram (mg)/24 hours; for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and <5% PCs in bone marrow; for sCR: CR plus normal free light chain (FLC) ratio, and Absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4- color flow cytometry.

    Measured: Up to 3 years and 4 months

Secondary outcomes (9)

  1. Overall Response Rate (ORR)

    ORR was defined as the percentage of participants who achieved partial response (PR) or better responses based on the computerized algorithm, in accordance with the IMWG criteria, during or after the study treatment but before the start of subsequent anti-myeloma therapy. IMWG criteria for PR: greater than or equal to (>=)50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or less than (<)200 mg/24 hours; If the serum and urine M-protein were not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria; If serum and urine M-protein were not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%; additionally, if present at baseline, >=50% reduction in the size of soft tissue PCs was also required.

    Measured: Up to 3 years and 7 months

  2. Percentage of Participants Achieving Complete Response (CR) or Better

    Percentage of participants achieving CR or better were reported. CR or better rate was defined as the percentage of participants achieving CR or sCR based on the computerized algorithm, according to IMWG response criteria. IMWG criteria for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and <5% PCs in bone marrow.

    Measured: Up to 3 years and 7 months

  3. Progression Free Survival (PFS)

    PFS was defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. IMWG criteria for PD: >=25% from lowest response level in serum M-component (the absolute increase must be >=0.5 gram per deciliter [g/dL]) and/or in urine M-component (the absolute increase must be >=200 mg/24 hour); only in participants without measurable serum and urine M-protein levels: increase of >=25% in the difference between involved and uninvolved free light chain levels and the absolute increase must be >10 mg/dL. BMPC%: the absolute % must be >=10%; 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 milligrams per deciliter (mg/dL) or 2.65 millimoles per liter [mmol/L]) that can be attributed solely to PC proliferative disorder.

    Measured: Up to 3 years and 7 months

  4. Overall Survival (OS)

    OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.

    Measured: Up to 3 years and 7 months

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

    Percentage of participants with negative MRD were reported. MRD negativity rate, defined as the percentage of participants who had MRD negative status at 10^-5 by bone marrow aspirate after the date of randomization and prior to PD or subsequent anti-myeloma therapy.

    Measured: Up to 3 years and 7 months

  6. Time to Next Treatment

    Time to next treatment was defined as the time from randomization to the start of the next-line treatment.

    Measured: Up to 3 years and 7 months

  7. Serum Concentrations of Daratumumab

    Serum concentrations of daratumumab were assessed. This outcome measure was planned to be analyzed for specified arm only.

    Measured: Day 1 of Cycles 1, 3, and 7 (each cycle of 28 days) and Follow Up (post treatment Week 8; up to 30.3 months)

  8. Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies

    The incidence of anti-rHuPH20 antibodies were summarized for all participants who received at least one dose of Dara-SC and had appropriate plasma samples for detection of antibodies to rHuPH20 (at least 1 sample after the start of the first dose of Dara-SC). This outcome measure was planned to be analyzed for specified arm only.

    Measured: Up to end of study; up to 30.3 months

  9. Number of Participants With Anti-Daratumumab Antibodies

    Number of participants who test positive for anti-daratumumab antibodies were reported. This outcome measure was planned to be analyzed for specified arm only.

    Measured: Up to end of study; up to 30.3 months

Timeline

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

  1. First posted12 Mar 2019
  2. Study start31 May 2019
  3. Primary completion24 Oct 2022
  4. Study completion10 Jan 2023

Why it stopped: The decision was made to discontinue the 54767414MMY2065 study as the Data Review Committee recommendation was early stop of the study for futility.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871829
Sponsor's protocol ID
CR108598
Other IDs
2018-004185-34, 54767414MMY2065, 2018
Status last verified
Mar 2025
First submitted
11 Mar 2019
Last updated
30 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Bahlis NJ, Zonder J, Karlin L, Plesner T, Paris L, Wrobel T, Hungria V, Besemer B, Crusoe E, Silkjaer T, Perrot A, Moreau P, Wu KL, Delimpasi S, Dimopoulos MA, Levin MD, Mangiacavalli S, Nnane I, Kim YJ, Krevvata M, Sha L, Wroblewski S, Tuozzo A, Carson R, Facon T. Subcutaneous daratumumab plus carfilzomib and dexamethasone (D-Kd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who received previous daratumumab treatment: LYNX study. Leuk Lymphoma. 2025 Dec;66(14):2685-2696. doi: 10.1080/10428194.2025.2561117. Epub 2025 Oct 3.

    PubMed 41041907

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carfilzomib 20 mg/m^2, Carfilzomib 70 mg/m^2 and Dexamethasone 40 mg in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 108 sites in 13 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: stopped early, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in Italy, Brazil, France, Spain, Germany and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Dec 2023). 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?

Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response (time frame: Up to 3 years and 4 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 NCT03871829, 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 Mar 2025.

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