A Clinical Study to evaluate the long-term safety of Daratumumab in combination with standard bone marrow cancer treatment regiments

Phase 3

Active, not recruiting

• Conditions: Multiple Myeloma

• Registration Number: 2022-500138-27-01
• Lead Sponsor: Janssen - Cilag International

Brief Summary

The primary objective of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen 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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2022-11-16
• Last Update Posted: 2025-05-27

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 73

Inclusion Criteria

Participants must:  be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen 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 female participant must be either of the following: a. Not of childbearing potential, or b. Of childbearing potential and practicing at least 1 highly effective method of contraception throughout the study and through 3 months after the last dose of daratumumab.

A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study for specified periods after the last dose of study treatment.

A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for specified periods after the last dose of study treatment. If partner is a female of childbearing potential, the male participant must use condom with spermicide and the partner must also be practicing a highly effective method of contraception. A male participant who is vasectomized must still use a condom (with or without spermicide), but the partner is not required to use contraception.

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 (eg, 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 IB and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide).

Vaccinated with an investigational vaccine (except for COVID-19) or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is when no more patients require continued access to Daratumumab via this study, which means they have discontinued study treatment or have other alternative access to Daratumumab.		Primary endpoint is when no more patients require continued access to Daratumumab via this study, which means they have discontinued study treatment or have other alternative access to Daratumumab.

Trial Locations

Locations (28)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Azienda Ospedaliera Policlinico Universitario Tor Vergata; 🇮🇹 Rome, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I; 🇮🇹 Rome, Italy

Wojewodzki Szpital Specjalistyczny W Legnicy; 🇵🇱 Legnica, Poland

Uniwersytecki Szpital Kliniczny W Poznaniu; 🇵🇱 Poznan, Poland

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Universitaetsklinikum Tuebingen; 🇩🇪 Tuebingen, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Ziekenhuis Aan De Stroom; 🇧🇪 Antwerp, Belgium

Region Midtjylland; 🇩🇰 Aarhus N, Denmark

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Fondazione IRCCS Policlinico San Matteo

🇮🇹Pavia, Italy

Silvia Mangiacavalli

Site contact

+390982503689

s.mangiacavalli@smatteo.pv.it