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NCT06398457 · ClinicalTrials.gov registry record · Early Phase 1
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
A Early Phase 1 study of Multiple Myeloma and Lymphoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT06398457 is a Early Phase 1 study of Multiple Myeloma and Lymphoma that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 8 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06398457, a Early Phase 1 study of Multiple Myeloma and Lymphoma, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a stem cell transplant.
Conditions Studied
Interventions
- DRUG Darzalex Faspro (Daratumumab and hyaluronidase-fihj)
- DEVICE JH-DSA Semi-Quant Screen and Response Score
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-09-19 |
| Est. Completion | 2027-03 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06398457
The ClinicalTrials.gov registry entry for NCT06398457 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Darzalex Faspro (Daratumumab and hyaluronidase-fihj) is the first listed.
NCT06398457 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06398457 about?
NCT06398457 is a clinical study titled "Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies". This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patien...
What is the current status of trial NCT06398457?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2024-09-19. Estimated completion is 2027-03.
What conditions does trial NCT06398457 study?
This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Hematologic Malignancy.
What interventions are being tested in trial NCT06398457?
The interventions under investigation include: Darzalex Faspro (Daratumumab and hyaluronidase-fihj) (DRUG), JH-DSA Semi-Quant Screen and Response Score (DEVICE).
Who is sponsoring clinical trial NCT06398457?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06398457 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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