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A Study of Daratumumab

Status
Active
Cancer Type
Multiple Myeloma
Plasma cell neoplasm
Trial Phase
Phase III
Eligibility
0 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05438043
Protocol IDs
CR109200 (primary)
NCI-2024-00436
2021-006494-33
2022-500138-27-00
54767414MMY3030
Study Sponsor
Janssen Research & Development, LLC

Summary

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.

Eligibility

  1. 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
  2. Investigator's assessment that the benefit of continued study treatment 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 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
  5. 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
  6. Willing and able to adhere to the lifestyle restrictions specified in this protocol

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.