NCT03412565CompletedPhase 2
A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
Source: ClinicalTrials.gov · Last updated 29 Apr 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 265 (actual)
- First submitted
- 22 Jan 2018
- Start date
- 26 Apr 2018
- Primary completion date
- 12 Aug 2020
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT03412565
- EudraCT number
- 2017-004203-41
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 265
- From 26 Apr 2018 to the primary completion date, 12 Aug 2020
- 64 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant 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
- Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (\<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension
- Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection (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) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded
- Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy
Lab values
- For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) \<40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmHg) or diastolic \>99 mmHg despite optimal treatment
Other
- Exhibits clinical signs of meningeal involvement of MM
Who the study is looking for
- Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Measurable, secretory disease as defined by any of the following:
- Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); or
- Urine M-protein level \>= 200 milligram per 24 hours (mg/24 hours); or
- Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) \>= 10 mg/dL and abnormal FLC ratio
- Meets one of the sets of the following criteria:
- For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
- For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
- D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
- During the study, during dose interruptions, and for 3 months after receiving the last dose of any component of the study treatment, a female participant must agree not to donate eggs (ova, oocytes) and male participants of reproductive potential must not donate semen or sperm during the study, during dose interruptions, or for 3 months after the last dose of any study drug
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (64)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Unknown status |
| Ministerio da Saude Instituto Nacional do Cancer Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Clinica Sao Germano Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Universitaetsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Asklepios Klinik Altona Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitaetsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Inst. Cat. D'Oncologia-Badalona Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Inst. Cat. Doncologia-H Duran I Reynals Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Univ Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Gral. Univ. Gregorio Maranon Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. Ramon Y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Son Llatzer Coordinator of this site? Confirm its status | Mallorca | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hosp. Univ. Dr. Peset Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU de Bordeaux - Hospital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| CHU Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| CHU Nancy-Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Heart of England NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Royal Bournemouth Hospital Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| Kent and Canterbury Hospital Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Unknown status |
| Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Galilee Medical Center Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Matsuyama Red Cross Hospital Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya City | Japan | Unknown status |
| Billings Clinic Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Karmonos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| San Juan Oncology Associates Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Nebraska Hematology and Oncology Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Southeast Nebraska Cancer Center Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| NYU Winthrop Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Mt. Sinai School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| UF Health Cancer Center at Orlando Health Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Utah Cancer Specialists Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Avera Medical Group - Oncology & Hematology Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Cancer Center Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| Cancer Center of Central Connecticut - Southington Coordinator of this site? Confirm its status | Southington | United States | Unknown status |
| Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.