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Search / Trial NCT05438043

A Study of Daratumumab

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 24, 2022

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called daratumumab for patients with multiple myeloma, a type of blood cancer, or smoldering multiple myeloma, which is a less aggressive form of the disease. The goal of the study is to continue providing access to daratumumab for patients who have already benefited from it in earlier research studies. This means that if you are currently receiving daratumumab as part of another study and have not had significant issues with the treatment, you may be eligible to participate in this trial and keep receiving the medication.

To be eligible, participants must be actively receiving daratumumab and have shown benefits from it in their previous studies. They also need to agree to certain safety measures, such as pregnancy tests for women and restrictions for men regarding sperm donation. Throughout the trial, researchers will keep track of any long-term safety information related to the treatment. If you decide to join, you can expect to continue receiving your treatment while contributing to important research that may help others in the future.

Gender

ALL

Eligibility criteria

  • 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

About Janssen Research & Development, Llc

Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.

Locations

New York, New York, United States

Pessac, , France

Ann Arbor, Michigan, United States

Dallas, Texas, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Paris, , France

Tianjin, , China

Paris, , France

Antwerpen, , Belgium

Pessac, , France

Beijing, , China

Chemnitz, , Germany

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Leeds, , United Kingdom

Hamburg, , Germany

Murcia, , Spain

Salamanca, , Spain

Shanghai, , China

Beijing, , China

Saratov, , Russian Federation

Goyang Si, , Korea, Republic Of

Guangzhou, , China

Saint Louis, Missouri, United States

Madrid, , Spain

Surrey, , United Kingdom

Seongnam, , Korea, Republic Of

Shanghai, , China

Zhengzhou, , China

Seoul, , Korea, Republic Of

Shanghai, , China

Saint Louis, Missouri, United States

Busan, , Korea, Republic Of

Fuzhou, , China

Moscow, , Russian Federation

Petrozavodsk, , Russian Federation

Syktyvkar, , Russian Federation

Madrid, , Spain

Cherkasy, , Ukraine

Dnepropetrovsk, , Ukraine

Vinnitsa, , Ukraine

Beijing, , China

Legnica, , Poland

Izmir, , Turkey

Madrid, , Spain

Madrid, , Spain

Nizhny Novgorod, , Russian Federation

Badalona, , Spain

Barcelona, , Spain

Madrid, , Spain

Changchun, , China

Pamplona, , Spain

Guangzhou, , China

Valencia, , Spain

Seoul, , Korea, Republic Of

Hangzhou, , China

Wenzhou, , China

Tübingen, , Germany

Chengdu, , China

Hangzhou, , China

Athens Attica, , Greece

St Petersburg, , Russian Federation

La Laguna, , Spain

Tours Cedex 9, , France

Ryazan, , Russian Federation

Madrid, , Spain

Caen, , France

New York, New York, United States

Aarhus N, , Denmark

Roma, , Italy

Hospitalet De Llobregat, Barcelona, , Spain

Nantes Cedex 1, , France

Hwasun, , Korea, Republic Of

Poznan, , Poland

Barcelona, , Spain

Saint Petersburg, , Russian Federation

Kharkov, , Ukraine

Goyang Si, , Korea, Republic Of

Thessaloniki, , Greece

Beijing, , China

Suzhou, , China

Chengdu, , China

Hangzhou, , China

Tianjin, , China

Shanghai, , China

Barcelona, , Spain

Salamanca, , Spain

Roma, , Italy

Hospitalet De Llobregat, , Spain

Patients applied

0 patients applied

Trial Officials

Janssen Research & Development, LLC Clinical Trial

Study Director

Janssen Research & Development, LLC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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