Clinical trial · Interventional
A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
An Open-label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DFRF4539A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: DFRF4539A
Primary outcomes (3)
- measure
- Safety: Incidence of adverse events
- timeFrame
- approximately 3.5 years
- measure
- Safety: Maximum tolerated dose/dose-limiting toxicities
- timeFrame
- approximately 1.5 years
- measure
- Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A
- timeFrame
- approximately 3.5 years
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients; \>/= 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Relapsed or refractory multiple myeloma for which no effective standard therapy exists * One of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug * Measurable disease as defined by protocol Exclusion Criteria: * Prior use of monoclonal antibody within 4 weeks before Cycle 1, Day 1 * Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1 * Toxicities from any previous treatment must be resolved prior to Cycle 1, Day 1, except for neuropathy * Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1 * Prior allogeneic stem cell transplant * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * Grade \> 1 peripheral neuropathy * Active infection at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1, Day 1 * Positive for hepatitis B, hepatitis C or HIV infection * Pregnant or lactating women or women who intend to become pregnant within the period of time of this study
References
Publications (0)
Data not yet available