Multiple Myeloma Clinical Trial
Official title:
A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | April 30, 2026 |
| Est. primary completion date | January 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | ZNA Stuivenberg | Antwerpen | |
| Denmark | Aarhus University Hospital | Aarhus N | |
| France | Centre Hospitalier Universitaire (CHU) de Caen | Caen | |
| France | CHU Nantes | Nantes Cedex 1 | |
| France | Hopital Saint Louis | Paris | |
| France | Hôpital Haut-Lévêque | Pessac | |
| Germany | Klinikum Chemnitz gGmbH | Chemnitz | |
| Germany | Asklepios Klinik Altona | Hamburg | |
| Germany | Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, | Tübingen | |
| Greece | Alexandra General Hospital of Athens | Athens Attica | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | National Cancer Center | Goyang-si | |
| Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | |
| Poland | Wojewodzki Szpital Specjalistyczny w Legnicy | Legnica | |
| Russian Federation | S.P. Botkin Moscow City Clinical Hospital | Moscow | |
| Russian Federation | Nizhniy Novgorod Region Clinical Hospital | Nizhny Novgorod | |
| Russian Federation | Republican Hospital named by V.A.Baranova | Petrozavodsk | |
| Russian Federation | Ryazan Regional Clinical Hospital | Ryazan | |
| Russian Federation | City Hospital No.15 | Saint-Petersburg | |
| Russian Federation | Saratov State Medical University | Saratov | |
| Russian Federation | Clinical Research Institute of Hematology and Transfusiology | St-Petersburg | |
| Russian Federation | Oncology Dispensary of Komi Republic | Syktyvkar | |
| Spain | Hosp. Univ. Germans Trias I Pujol | Badalona | |
| Spain | Hosp. Clinic de Barcelona | Barcelona | |
| Spain | Centro Integral Oncológico Clara Campal | Madrid | |
| Spain | Clinica Univ. de Navarra | Madrid | |
| Spain | Hosp. Gral. Univ. Gregorio Maranon | Madrid | |
| Spain | Hosp. Univ. 12 de Octubre | Madrid | |
| Spain | Hosp. Univ. Ramon Y Cajal | Madrid | |
| Spain | Hosp. Gral. Univ. J.M. Morales Meseguer | Murcia | |
| Spain | Clinica Univ. de Navarra | Pamplona | |
| Spain | Hosp. Clinico Univ. de Salamanca | Salamanca | |
| Spain | Hosp. Univ. Dr. Peset | Valencia | |
| Ukraine | Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' | Cherkasy | |
| Ukraine | Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center | Dnepropetrovsk | |
| Ukraine | Kharkov Regional Clinical Oncology Center, Dept. of Hematology | Kharkov | |
| Ukraine | Vinnytsya Regional Clinical Hospital named after M.I.Pirogov | Vinnitsa | |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | Washington University in St. Louis | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Research & Development, LLC |
United States, Belgium, Denmark, France, Germany, Greece, Korea, Republic of, Poland, Russian Federation, Spain, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Serious Adverse Events (SAEs) | Number of participants with SAEs will be reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. | 3 years 7 months | |
| Primary | Number of Participants with AEs of Special Interest (AESI) | Number of participants with AESI, that is, reactivation of HBV infection, will be reported. | 3 years 7 months | |
| Primary | Number of Participants with Pregnancies or Partner Pregnancies | Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form. | 3 years 7 months | |
| Primary | Number of Participants with Abnormal Pregnancies as SAE | Number of Participants with Abnormal Pregnancies as SAE will be reported. | 3 years 7 months |
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