AzTrials
AzTrials

Multiple MyelomaPhase 3NCT03277105

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing Dara SC and Dara IV in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 146 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 show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough). 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?
Dara SC and Dara IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
522 participants
Where
146 sitesin 18 countries
Study dates
27 Oct 2017to 12 Jan 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

  • Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
  • Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). 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/day [mg/day] for 4 days) would not be considered prior lines of therapy
  • Documented multiple myeloma as defined by the criteria below:
  • Multiple myeloma diagnosis according to the IMWG diagnostic criteria
  • Measurable disease at Screening as defined by any of the following:
  • Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
Show all 10Show fewer
  • Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Meet the clinical laboratory criteria as specified in the protocol
  • Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization

Who cannot join

  • Received daratumumab or other anti-CD38 therapies previously
  • Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
  • Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
  • Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
  • 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

Trial locations and contacts

146 sites in 18 countries.

146 sites in 18 countries

Japan16 sites

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Chugoku Central Hospital

    Fukuyama, 720-0001

  • Ogaki Municipal Hospital

    Gifu, 503-8502

  • Gunma University Hospital

    Gunma, 371-0034

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, 466-8650

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Iwate Medical University Hospital

    Numakunai, 020-8505

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Osaka University Hospital

    Osaka, 565-0871

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa, 377-0280

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935

Other trials in Japan

Spain13 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Hosp. de Leon

    León, 24008

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320

  • Hosp. Univ. Dr. Peset

    Valencia, 46017

Other trials in Spain

Brazil11 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

    Florianópolis, 88034-000

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210 080

  • Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

    Joinville, 89201-260

  • Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

    Passo Fundo, 99010-090

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Instituto de Educacao, Pesquisa e Gestao em Saude

    Rio de Janeiro, 22775-001

  • CEHON

    Salvador, 45995-000

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090-000

  • Clinica Sao Germano

    São Paulo, 01455 010

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-010

Other trials in Brazil

Russia11 sites

  • Emergency Hospital of Dzerzhinsk

    Dzerzhinsk, 606019

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284

  • City Clinical Hospital # 40

    Moscow, 129301

  • Nizhniy Novgorod Region Clinical Hospital

    Nizny Novgorod, 603126

  • Penza Regional Oncology Dispensary

    Penza, 440071

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039

  • Saint Petersburg City Hospital #15

    Saint Petersburg, 123182

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024

  • Samara Region Clinical Hospital

    Samara, 443095

  • Oncology Dispensary of Komi Republic

    Syktyvkar, 167904

  • Ekaterinburg City Clinical Hospital # 7

    Yekaterinburg, 620137

Other trials in Russia

Ukraine10 sites

  • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

    Cherkasy, 18009

  • Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

    Dnipro, 49102

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

    Kharkiv, 61024

  • National Cancer Institute, Dept. of chemotherapy of hemoblastosis

    Kiev, 03022

  • Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department

    Kiev, 03115

  • State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'

    Kiev, 03115

  • Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

    Lviv, 79044

  • Mykolaiv Regional Clinical Hospital

    Mykolaiv, 54000

  • Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital

    Poltava, 36011

Other trials in Ukraine

Poland9 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozów, 36-200

  • Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31 501

  • Wojewodzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, 20-081

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im Karola Marcinkowskiego

    Poznan, 60 569

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

United Kingdom9 sites

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Leicester Royal Infirmary - Haematology

    Leicester, LE1 5WW

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Guys St Thomas Hospital

    London, SE1 9RT

  • Christie Hospital NHS Trust

    Manchester, M20 9BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Royal Marsden Hospital

    Surrey, SM2 5PT

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia8 sites

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Alfred Health

    Melbourne, 3004

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Calvary Mater Newcastle Hospital

    Waratah, 2298

  • The Queen Elizabeth Hospital

    Woodville South, 5011

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Italy8 sites

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda USL di Piacenza

    Piacenza, 29121

  • Università di Roma La Sapienza

    Roma, 00161

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • A.O.U. Città della Salute e della Scienza

    Torino, 10126

Other trials in Italy

South Korea8 sites

  • Pusan National University Hospital

    Busan, 49241

  • National Cancer Center

    Goyang-si, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Victoria Hospital

    London, Ontario, N6A 5W9

  • CHU de Quebec L Hotel Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 1X6

  • The Gordon & Leslie Diamond Health Care Center

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Czechia7 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni Nemocnice Ostrava

    Ostrava, 70852

  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

    Pilsen, 323 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

    Prague, 128 08

Other trials in Czechia

France7 sites

  • CHU Caen - Côte de Nacre

    Caen, 14033

  • Hopital Claude Huriez

    Lille, 59000

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • CHU de Boreaux

    Pessac, 33604

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Israel7 sites

  • Hillel Yaffe Medical Center - Oncology

    Hadera, 38100

  • Rambam Med.Center - Hematology Institute

    Haifa, 31096

  • Carmel Medical Center

    Haifa, 3436212

  • Hadassah Medical Center

    Jerusalem, 91120

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100

  • Sheba Medical Center Tel Hashomer

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Sweden6 sites

  • Falu Lasarett

    Falun, 79182

  • Helsingborgs lasarett

    Helsingborg, 25187

  • Karolinska University Hospital Huddinge

    Huddinge, 141 86

  • Skanes universitetssjukhus

    Lund, 222 41

  • Norrlands University Hospital

    Umeå, 907 46

  • Akademiska Sjukhuset

    Uppsala, SE-751 85

Other trials in Sweden

Taiwan6 sites

  • Chang-Hua Christian Hospital

    Changhua, 50006

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10048

  • Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

United States2 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

Other trials in United States

Greece1 site

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28

Other trials in Greece

About this study

Official title: A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).

Read the detailed description

The study population will consist of adults diagnosed with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD. The study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a follow-up phase. Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be assessed at scheduled time. Follow-up will continue until the end of the data collection period, approximately 24 months after the last participant was randomized or when the median overall survival for both arms has been reached, whichever occurs first. The primary hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram (mg) are not inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per kilogram (mg/kg) in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD.

Being tested
Dara SC, Dara IV
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Dara SCDrug

    Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.

  • Dara IVDrug

    Also called JNJ-54767414

    Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.

Study groups in NCT03277105
Study groupRoleWhat they receive
Dara SCExperimentalParticipants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.
Receives: Drug: Dara SC
Dara IVActive comparatorParticipants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
Receives: Drug: Dara SC; Drug: Dara IV

What is being measured

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

  1. Overall Response Rate (ORR)

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

    Measured: Up to 1 year 8 months

  2. Maximum Trough Concentration (Ctrough) of Daratumumab

    Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.

    Measured: Predose on Cycle 3 Day 1 (each cycle of 28 days)

Secondary outcomes (11)

  1. Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)

    Percentage of participants with treatment-emergent infusion-related reactions were reported.

    Measured: Up to 3 years

  2. Progression Free Survival (PFS)

    PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be >=0.5 gram per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

    Measured: Up to 3 years

  3. Percentage of Participants With Very Good Partial Response (VGPR) or Better

    VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.

    Measured: Up to 3 years

  4. Percentage of Participants With Complete Response (Including sCR) or Better

    CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.

    Measured: Up to 3 years

  5. Time to Next Therapy

    Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.

    Measured: Up to 3 years

  6. 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

  7. Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)

    Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.

    Measured: Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)

  8. Duration of Response

    Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

    Measured: Up to 3 years

  9. Time to Partial Response (PR) or Better

    Time to PR or better was defined as the time from randomization until onset of first response of PR or better.

    Measured: Up to 3 years

  10. Time to Very Good Partial Response (VGPR) or Better

    Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.

    Measured: Up to 3 years

  11. Time to Complete Response (CR) or Better

    Time to CR or better was defined as the time from randomization until onset of first CR or better.

    Measured: Up to 3 years

Timeline

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

  1. First posted8 Sep 2017
  2. Study start27 Oct 2017
  3. Primary completion27 Jun 2019
  4. Study completion12 Jan 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
522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03277105
Sponsor's protocol ID
CR108342
Other IDs
2017-000206-38, 54767414MMY3012, 2017
Status last verified
Apr 2025
First submitted
7 Sep 2017
Last updated
29 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

    PubMed 39971605

  • Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6.

    PubMed 37022569

  • Usmani SZ, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis NJ, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Lantz K, O'Rourke L, Heuck C, Delioukina M, Qin X, Nnane I, Qi M, Mateos MV. Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. Haematologica. 2022 Oct 1;107(10):2408-2417. doi: 10.3324/haematol.2021.279459.

    PubMed 35354247

  • Iida S, Ishikawa T, Min CK, Kim K, Yeh SP, Usmani SZ, Mateos MV, Nahi H, Heuck C, Qin X, Parasrampuria DA, Gries KS, Qi M, Bahlis N, Ito S. Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study. Ann Hematol. 2021 Apr;100(4):1065-1077. doi: 10.1007/s00277-021-04405-2. Epub 2021 Feb 18.

    PubMed 33599794

  • Usmani SZ, Mateos MV, Hungria V, Iida S, Bahlis NJ, Nahi H, Magen H, Cavo M, Hulin C, White D, De Stefano V, Fastenau J, Slavcev M, Heuck C, Qin X, Pei H, Masterson T, Lantz K, Gries KS. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.

    PubMed 32852632

  • Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23.

    PubMed 32213342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dara SC and Dara IV in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 146 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 10 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in Japan, Spain, Brazil, Russia, Ukraine 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 27 Jul 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?

Overall Response Rate (ORR) (time frame: Up to 1 year 8 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 NCT03277105, which also lists 6 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 29 Apr 2025.

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