A Study of Daratumumab

Last Updated April 30, 2025

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CR109200

OVERVIEW

Sexes Eligible for Study
all
Age
+ years
Phase
phase 3

3
Sites
76 Sites
Status

Recruiting

SUMMARY

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

Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

* Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R&D) studies or receiving other study treatment in a Janssen R&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months
* Investigator's assessment that the benefit of continued study treatment will outweigh the risks
* A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment
* Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

* Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide)
* Vaccinated with an investigational vaccine (except for Coronavirus disease [COVID-19])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Belgium, China, Denmark, France, Germany, Greece, South Korea, Poland, Russia, Spain, Ukraine, Italy, Türkiye, United Kingdom

Country (15)	City or Province (76)	Status
United States	New York Memorial Sloan Kettering Cancer Center	ACTIVE_NOT_RECRUITING
United States	Dallas Baylor University Medical Center	ACTIVE_NOT_RECRUITING
Belgium	Antwerpen ZNA Stuivenberg	ACTIVE_NOT_RECRUITING
China	Beijing Peking Union Medical College Hospital	ACTIVE_NOT_RECRUITING
China	Beijing Beijing Chaoyang Hospital	ACTIVE_NOT_RECRUITING
China	Beijing Peking University First Hospital	RECRUITING
China	Beijing Peking University People s Hospital	ACTIVE_NOT_RECRUITING
China	Changchun The First Bethune Hospital of Jilin University	ACTIVE_NOT_RECRUITING
China	Chengdu West China Hospital Si Chuan University	ACTIVE_NOT_RECRUITING
China	Fuzhou Fujian Medical University	ACTIVE_NOT_RECRUITING
China	Guangzhou Guangdong General Hospital	ACTIVE_NOT_RECRUITING
China	Guangzhou Nanfang Hospital	ACTIVE_NOT_RECRUITING
China	Hangzhou First Affiliated Hospital Medical School of Zhejiang University	ACTIVE_NOT_RECRUITING
China	Hangzhou First affiliated Hospital of Zhejiang University	ACTIVE_NOT_RECRUITING
China	Shanghai Shanghai Changzheng Hospital	RECRUITING
China	Shanghai Ruijin Hospital Shanghai Jiao Tong University	RECRUITING
China	Suzhou First Affiliated Hospital SooChow University	RECRUITING
China	Tianjin Tianjin cancer hospital	ACTIVE_NOT_RECRUITING
China	Tianjin Institute of Hematology and Blood Diseases Hospital	ACTIVE_NOT_RECRUITING
China	Wenzhou The First Affiliated Hospital of Wenzhou Medical University	ACTIVE_NOT_RECRUITING
China	Zhengzhou Henan Cancer Hospital	COMPLETED
Denmark	Aarhus N Aarhus University Hospital	ACTIVE_NOT_RECRUITING
France	Nantes Cedex 1 CHU Nantes	ACTIVE_NOT_RECRUITING
France	Paris Hopital Saint Louis	ACTIVE_NOT_RECRUITING
Germany	Chemnitz Klinikum Chemnitz gGmbH	ACTIVE_NOT_RECRUITING
Germany	Hamburg Asklepios Klinik Altona	ACTIVE_NOT_RECRUITING
Greece	Athens Attica Alexandra General Hospital of Athens	ACTIVE_NOT_RECRUITING
South Korea	Busan Pusan National University Hospital	ACTIVE_NOT_RECRUITING
South Korea	Hwasun Chonnam National University Hwasun Hospital	ACTIVE_NOT_RECRUITING
South Korea	Seongnam Seoul National University Bundang Hospital	ACTIVE_NOT_RECRUITING
South Korea	Seoul Seoul National University Hospital	ACTIVE_NOT_RECRUITING
South Korea	Seoul Samsung Medical Center	ACTIVE_NOT_RECRUITING
South Korea	Seoul The Catholic University of Korea Seoul St Marys Hospital	ACTIVE_NOT_RECRUITING
Poland	Legnica Wojewodzki Szpital Specjalistyczny w Legnicy	ACTIVE_NOT_RECRUITING
Russia	Moscow S.P. Botkin Moscow City Clinical Hospital	RECRUITING
Russia	Nizhny Novgorod Nizhniy Novgorod Region Clinical Hospital	RECRUITING
Russia	Petrozavodsk Republican Hospital named by V.A.Baranova	RECRUITING
Russia	Ryazan Ryazan Regional Clinical Hospital	RECRUITING
Russia	Saint-Petersburg City Hospital No.15	RECRUITING
Russia	Saratov Saratov State Medical University	RECRUITING
Russia	St-Petersburg Clinical Research Institute of Hematology and Transfusiology	RECRUITING
Russia	Syktyvkar Oncology Dispensary of Komi Republic	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	ACTIVE_NOT_RECRUITING
Spain	La Laguna Hosp. Univ. de Canarias	ACTIVE_NOT_RECRUITING
Spain	Madrid Hosp. Gral. Univ. Gregorio Maranon	ACTIVE_NOT_RECRUITING
Spain	Madrid Clinica Univ. de Navarra	ACTIVE_NOT_RECRUITING
Spain	Madrid Hosp. Univ. Ramon Y Cajal	ACTIVE_NOT_RECRUITING
Spain	Madrid Hosp. Univ. 12 de Octubre	ACTIVE_NOT_RECRUITING
Spain	Madrid Centro Integral Oncológico Clara Campal	ACTIVE_NOT_RECRUITING
Spain	Murcia Hosp. Gral. Univ. J.M. Morales Meseguer	COMPLETED
Spain	Pamplona Clinica Univ. de Navarra	ACTIVE_NOT_RECRUITING
Spain	Salamanca Hosp Clinico Univ de Salamanca	ACTIVE_NOT_RECRUITING
Spain	Valencia Hosp. Univ. Dr. Peset	ACTIVE_NOT_RECRUITING
Ukraine	Cherkasy Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'	ACTIVE_NOT_RECRUITING
Ukraine	Dnepropetrovsk Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center	ACTIVE_NOT_RECRUITING
Ukraine	Kharkov Kharkov Regional Clinical Oncology Center, Dept. of Hematology	ACTIVE_NOT_RECRUITING
Ukraine	Vinnitsa Vinnytsya Regional Clinical Hospital named after M.I.Pirogov	ACTIVE_NOT_RECRUITING
United States	Miami University of Miami Sylvester Cancer Center	ACTIVE_NOT_RECRUITING
United States	Atlanta Emory University	ACTIVE_NOT_RECRUITING
United States	Ann Arbor University of Michigan Comprehensive Cancer Center	ACTIVE_NOT_RECRUITING
United States	New York Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg	ACTIVE_NOT_RECRUITING
China	ShangHai Renji Hospital, Shanghai Jiaotong University School of Medicine	ACTIVE_NOT_RECRUITING
France	Caen Centre Hospitalier Universitaire (CHU) de Caen	COMPLETED
France	Pessac Hopital Haut Leveque	COMPLETED
Germany	Tübingen Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,	COMPLETED
Poland	Poznan Uniwersytecki Szpital Kliniczny w Poznaniu	ACTIVE_NOT_RECRUITING
Spain	Badalona Hosp. Univ. Germans Trias I Pujol	ACTIVE_NOT_RECRUITING
United States	Saint Louis Barnes-jewish Hospital	ACTIVE_NOT_RECRUITING
Greece	Thessaloniki Anticancer Hospital of Thessaloniki Theageneio	COMPLETED
Italy	Roma Universita Degli Studi di Roma Tor Vergata	COMPLETED
Italy	Roma Sapienza University of Rome	COMPLETED
South Korea	Goyang si National Cancer Center	ACTIVE_NOT_RECRUITING
Spain	Hospitalet de Llobregat Inst. Cat. Doncologia-H Duran I Reynals	ACTIVE_NOT_RECRUITING
Türkiye	Izmir Ege Universitesi Tip Fakultesi	RECRUITING
United Kingdom	Leeds St James University Hospital	ACTIVE_NOT_RECRUITING
United Kingdom	Surrey Royal Marsden Hospital	ACTIVE_NOT_RECRUITING

Geo Locations

40.71427, -74.00597

32.78306, -96.80667

51.21989, 4.40346

39.9075, 116.39723

43.88, 125.32278

30.66667, 104.06667

26.06139, 119.30611

23.11667, 113.25

30.29365, 120.16142

31.22222, 121.45806

31.30408, 120.59538

39.14222, 117.17667

27.99942, 120.66682

34.75778, 113.64861

56.15674, 10.21076

47.21725, -1.55336

48.85341, 2.3488

50.8357, 12.92922

53.57532, 10.01534

37.9804964, 23.7561153

35.10278, 129.04028

35.06125, 126.98746

37.43861, 127.13778

37.566, 126.9784

51.21006, 16.1619

55.75222, 37.61556

56.32867, 44.00205

61.78491, 34.34691

54.6269, 39.6916

59.93863, 30.31413

51.54056, 46.00861

59.93863, 30.31413

61.67642, 50.80994

41.38879, 2.15899

28.4853, -16.32014

40.4165, -3.70256

37.98704, -1.13004

42.81687, -1.64323

40.96882, -5.66388

39.46975, -0.37739

49.42854, 32.06207

48.4593, 35.03864

49.98081, 36.25272

49.84639, 37.71861

25.77427, -80.19366

33.749, -84.38798

42.27756, -83.74088

40.71427, -74.00597

31.22222, 121.45806

49.18585, -0.35912

44.81011, -0.64129

48.52266, 9.05222

52.40692, 16.92993

41.45004, 2.24741

38.62727, -90.19789

40.64361, 22.93086

41.89193, 12.51133

37.65639, 126.835

41.35967, 2.10028

38.41273, 27.13838

53.79648, -1.54785

51.3434765, -0.1910896

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

40.71427, -74.00597

32.78306, -96.80667

51.21989, 4.40346

39.9075, 116.39723

39.9075, 116.39723

39.9075, 116.39723

39.9075, 116.39723

43.88, 125.32278

30.66667, 104.06667

26.06139, 119.30611

23.11667, 113.25

23.11667, 113.25

30.29365, 120.16142

30.29365, 120.16142

31.22222, 121.45806

31.22222, 121.45806

31.30408, 120.59538

39.14222, 117.17667

39.14222, 117.17667

27.99942, 120.66682

34.75778, 113.64861

56.15674, 10.21076

47.21725, -1.55336

48.85341, 2.3488

50.8357, 12.92922

53.57532, 10.01534

37.9804964, 23.7561153

35.10278, 129.04028

35.06125, 126.98746

37.43861, 127.13778

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

51.21006, 16.1619

55.75222, 37.61556

56.32867, 44.00205

61.78491, 34.34691

54.6269, 39.6916

59.93863, 30.31413

51.54056, 46.00861

59.93863, 30.31413

61.67642, 50.80994

41.38879, 2.15899

28.4853, -16.32014

40.4165, -3.70256

40.4165, -3.70256

40.4165, -3.70256

40.4165, -3.70256

40.4165, -3.70256

37.98704, -1.13004

42.81687, -1.64323

40.96882, -5.66388

39.46975, -0.37739

49.42854, 32.06207

48.4593, 35.03864

49.98081, 36.25272

49.84639, 37.71861

25.77427, -80.19366

33.749, -84.38798

42.27756, -83.74088

40.71427, -74.00597

31.22222, 121.45806

49.18585, -0.35912

44.81011, -0.64129

48.52266, 9.05222

52.40692, 16.92993

41.45004, 2.24741

38.62727, -90.19789

40.64361, 22.93086