A clinical study to evaluate the long-term safety of daratumumab in combination with standard bone marrow cancer treatment regiments

Phase 3

• Conditions: Multiple myeloma; Cancer

• Registration Number: ISRCTN99312021
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-02
• Last Update Posted: 9 September 2024
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Participants must:
• be actively receiving daratumumab (either as monotherapy or in combination with other therapy) in a Janssen R&D-sponsored daratumumab study for participants with multiple myeloma which has reached clinical cutoff for final analysis,
• be enrolled in the parent study for a minimum of 12 months prior to rolling over,
• 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 daratumumab within the previous 3 months.
2. Investigator’s assessment that the benefit of continued daratumumab therapy will outweigh the risks.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Willing and able to adhere to the lifestyle restrictions specified in this protocol.

Exclusion Criteria

1. 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.
2. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
3. 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).
4. Vaccinated with an investigational vaccine (except for COVID-19) or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrolment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified