Actively Recruiting

Phase 3
All Genders
NCT05438043

A Study of Daratumumab

Led by Janssen Research & Development, LLC · Updated on 2026-05-08

500

Participants Needed

91

Research Sites

319 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

CONDITIONS

Official Title

A Study of Daratumumab

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be actively receiving daratumumab (alone or combined with other treatments) in certain Janssen studies for multiple myeloma or smoldering multiple myeloma that have reached clinical cutoff for final analysis
  • Participants must continue to benefit from treatment without disease progression or unmanageable toxicity
  • Participants must not have met withdrawal criteria in their previous study
  • Participants must have received their last dose of study treatment within the previous 3 months
  • Investigator must assess that treatment benefits outweigh risks
  • Female participants of childbearing potential must have a negative pregnancy test at screening and agree to ongoing pregnancy testing
  • Male participants must agree not to donate sperm for reproduction during the study and for at least 3 months after the last dose
  • Participants (or their legal representative) must sign informed consent
  • Participants must be willing and able to follow lifestyle restrictions specified in the protocol
Not Eligible

You will not qualify if you...

  • Participants who have taken disallowed therapies or treatments for multiple myeloma between the end of their previous study and the planned first dose in this study
  • Participants with any condition that the investigator believes would not be in their best interest or could affect study assessments
  • Known allergies, hypersensitivity, or intolerance to study treatments or their ingredients
  • Participants vaccinated with investigational vaccines (except COVID-19 vaccines) or live attenuated or replicating viral vector vaccines within 4 weeks before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 91 locations

1

University of Miami Sylvester Cancer Center

Miami, Florida, United States, 33136

Active, Not Recruiting

2

Emory University

Atlanta, Georgia, United States, 30322

Active, Not Recruiting

3

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Active, Not Recruiting

4

Barnes-jewish Hospital

St Louis, Missouri, United States, 63108

Active, Not Recruiting

5

Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

New York, New York, United States, 10029

Completed

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Completed

7

Baylor University Medical Center

Dallas, Texas, United States, 75246

Completed

8

ZAS Cadix

Antwerp, Belgium, 2030

Active, Not Recruiting

9

UNICAMP

Campinas, Brazil, 13083-970

Active, Not Recruiting

10

Liga Norte Riograndense Contra O Cancer

Natal, Brazil, 59062 000

Active, Not Recruiting

11

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil, 90610 000

Active, Not Recruiting

12

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, Brazil, 20230-130

Active, Not Recruiting

13

COI Clinicas Oncologicas Integradas

Rio de Janeiro, Brazil, 22793 080

Active, Not Recruiting

14

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil, 01323 010

Actively Recruiting

15

Clinica Medica Sao Germano S/S LTDA

São Paulo, Brazil, 04537-081

Active, Not Recruiting

16

Peking Union Medical College Hospital

Beijing, China, 100006

Active, Not Recruiting

17

Beijing Chaoyang Hospital

Beijing, China, 100020

Active, Not Recruiting

18

Peking University First Hospital

Beijing, China, 100034

Completed

19

Peking University People's Hospital

Beijing, China, 100044

Active, Not Recruiting

20

The First Bethune Hospital of Jilin University

Changchun, China, 130021

Active, Not Recruiting

21

West China Hospital Si Chuan University

Chengdu, China, 610041

Active, Not Recruiting

22

Fujian Medical University

Fuzhou, China, 350001

Active, Not Recruiting

23

Guangdong General Hospital

Guangzhou, China, 510080

Active, Not Recruiting

24

Nanfang Hospital

Guangzhou, China, 510515

Active, Not Recruiting

25

First Affiliated Hospital Medical School of Zhejiang University

Hangzhou, China, 310020

Active, Not Recruiting

26

First affiliated Hospital of Zhejiang University

Hangzhou, China, 310020

Active, Not Recruiting

27

Shanghai Changzheng Hospital

Shanghai, China, 200003

Active, Not Recruiting

28

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, China, 200025

Active, Not Recruiting

29

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China, 200127

Active, Not Recruiting

30

The First Affiliated Hospital of Soochow University

Suzhou, China, 215002

Active, Not Recruiting

31

Tianjin cancer hospital

Tianjin, China, 300060

Completed

32

Institute of Hematology and Blood Diseases Hospital

Tianjin, China, 300320

Active, Not Recruiting

33

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China, 325000

Active, Not Recruiting

34

Henan Cancer Hospital

Zhengzhou, China, 450008

Completed

35

Fakultni nemocnice Brno

Brno, Czechia, 62500

Active, Not Recruiting

36

Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)

Pilsen, Czechia, 304 60

Active, Not Recruiting

37

Všeobecná fakultní nemocnice v

Prague, Czechia, 128 08

Active, Not Recruiting

38

Aarhus University Hospital

Aarhus N, Denmark, DK-8200

Completed

39

Centre Hospitalier Universitaire (CHU) de Caen

Caen, France, 14033

Completed

40

CHU Nantes

Nantes, France, 44000

Completed

41

Hopital Saint Louis

Paris, France, 75010

Active, Not Recruiting

42

Hopital Haut Leveque

Pessac, France, 33604

Completed

43

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 09113

Active, Not Recruiting

44

Asklepios Klinik Altona

Hamburg, Germany, 22763

Active, Not Recruiting

45

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tübingen, Germany, 72076

Completed

46

Alexandra General Hospital of Athens

Athens Attica, Greece, 115 28

Active, Not Recruiting

47

Universita Degli Studi di Roma Tor Vergata

Roma, Italy, 00133

Completed

48

Sapienza University of Rome

Roma, Italy, 00161

Completed

49

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, Poland, 59-220

Active, Not Recruiting

50

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland, 60-569

Active, Not Recruiting

51

S.P. Botkin Moscow City Clinical Hospital 1

Moscow, Russia, 125284

Active, Not Recruiting

52

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia, 125284

Active, Not Recruiting

53

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, Russia, 603126

Active, Not Recruiting

54

Republican Hospital named by V.A.Baranova

Petrozavodsk, Russia, 185019

Active, Not Recruiting

55

Ryazan Regional Clinical Hospital

Ryazan, Russia, 390003

Active, Not Recruiting

56

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, Russia, 191024

Active, Not Recruiting

57

City Hospital No.15

Saint Petersburg, Russia, 198205

Active, Not Recruiting

58

Saratov State Medical University

Saratov, Russia, 410012

Active, Not Recruiting

59

Oncology Dispensary of Komi Republic

Syktyvkar, Russia, 167904

Active, Not Recruiting

60

Pusan National University Hospital

Busan, South Korea, 49241

Active, Not Recruiting

61

National Cancer Center

Goyang-si, South Korea, 10408

Active, Not Recruiting

62

Chonnam National University Hwasun Hospital

Hwasun, South Korea, 519-800

Active, Not Recruiting

63

Seoul National University Bundang Hospital

Seongnam, South Korea, 13620

Active, Not Recruiting

64

Seoul National University Hospital

Seoul, South Korea, 03080

Active, Not Recruiting

65

Samsung Medical Center

Seoul, South Korea, 06351

Active, Not Recruiting

66

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea, 06591

Active, Not Recruiting

67

Hosp. Univ. Fundacion Alcorcon

Alcorcón, Spain, 28922

Active, Not Recruiting

68

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain, 08916

Active, Not Recruiting

69

Hosp. Del Mar

Barcelona, Spain, 08003

Active, Not Recruiting

70

Hosp Clinic de Barcelona

Barcelona, Spain, 08036

Active, Not Recruiting

71

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, Spain, 08908

Active, Not Recruiting

72

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain, 28007

Active, Not Recruiting

73

Clinica Univ. de Navarra 1

Madrid, Spain, 28027

Completed

74

Hosp. Univ. Ramon Y Cajal

Madrid, Spain, 28034

Completed

75

Hosp. Univ. 12 de Octubre

Madrid, Spain, 28041

Active, Not Recruiting

76

Centro Integral Oncológico Clara Campal

Madrid, Spain, 28050

Completed

77

Hosp. Gral. Univ. J.M. Morales Meseguer

Murcia, Spain, 30008

Completed

78

Clinica Univ. de Navarra

Pamplona, Spain, 31008

Active, Not Recruiting

79

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain, 28223

Active, Not Recruiting

80

Hosp Clinico Univ de Salamanca

Salamanca, Spain, 37007

Active, Not Recruiting

81

Hosp. Univ. de Canarias

San Cristóbal de La Laguna, Spain, 38320

Active, Not Recruiting

82

Hosp. Mutua Terrassa

Terrassa, Spain, 08221

Active, Not Recruiting

83

Hosp. Univ. Dr. Peset

Valencia, Spain, 46017

Completed

84

Ege Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye), 35100

Active, Not Recruiting

85

CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC

Cherkasy, Ukraine, 18009

Active, Not Recruiting

86

Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council

Dnipro, Ukraine, 49102

Active, Not Recruiting

87

MNE Regional Oncology Center

Kharkiv, Ukraine, 61070

Active, Not Recruiting

88

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnitsa, Ukraine, 21018

Active, Not Recruiting

89

St James University Hospital

Leeds, United Kingdom, LS9 7TF

Active, Not Recruiting

90

Leicester Royal Infirmary Haematology

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

91

Royal Marsden Hospital

Surrey, United Kingdom, SM2 5PT

Active, Not Recruiting

Loading map...

Research Team

S

Study Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here