NCT07341867RecruitingPhase 1
Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype
A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This study is comprised of a main study, an observational study, and optional survey studies. The main study is being done to see whether using Duffy null specific treatment dosing guidelines can reduce or delay dose modifications and avoid neutropenic fever (fever in the setting of low neutrophils) for people with Duffy null phenotype receiving treatment for multiple myeloma or triple negative breast cancer. The observational study is to collect dose modification and neutropenic fever information on patients who do not have the Duffy null phenotype and receive the same standard of care regimens to see if there are differences in dose modifications and neutropenic fever between the two groups. The survey studies seek to understand general health experiences and preferences and experiences specific to people with Duffy null phenotype. Study Drugs Include: * Daratumumab * lenalidomide * bortezomib * dexamethasone * carboplatin * paclitaxel * pembrolizumab * cyclophosphamide * doxorubicin
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 30 Jul 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Andrew Hantel, MD
- NCT number
- NCT07341867
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 90
- From 30 Jul 2026 to the primary completion date, 31 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have started treatment at the time of enrollment cannot have started Cycle 2 of therapy
- Participants in Cohort 2 (TNBC) cannot have received any of the pembrolizumab, doxorubicin, and cyclophosphamide portion of therapy
- Participants receiving any other investigational agents for any indication
Lab values
- ANC\<500 within 7 days of planned start of Cycle 1 Day 1.
- Another known condition or medicine with known impacts on neutrophil counts or neutrophil function
Other
- Inability to understand and the willingness to sign a written informed consent document
Who the study is looking for
- Diagnosis of:
- Cohort 1: MM, based on IMWG criteria12, and currently requires treatment
- Cohort 2: Stage II or III TNBC, with definition per protocol Section 3.2.1 AND
- Plan for treatment, per their treating physician, or currently receiving their first cycle (see 3.3.3 for definition) of:
- Cohort 1: Dara-RVd for MM
- Cohort 2: A Keynote 522-based regimen of carboplatin, paclitaxel, and pembrolizumab given as the first phase of neoadjuvant treatment for TNBC.\*\*\*
- Participants are eligible even if the duration of carboplatin and paclitaxel goes beyond 4 cycles, or if the use of pembrolizumab, doxorubicin, and cyclophosphamide is not planned or is not certain, as long as neoadjuvant treatment starts with carboplatin-paclitaxel-pembrolizumab. This cohort will be referred to as "Keynote 522" for the remainder of the protocol.
- AND
- Confirmed Duffy null phenotype
- Previous testing is acceptable if performed by a CLIA-approved test
- AND
- Age \>=18 years old
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The Christ Hospital Cancer Center-Research Coordinator of this site? Confirm its status | Cincinnati | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.