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Duffy Null Phenotype and Cancer Treatment Dosing

This study is looking at how to adjust doses of cancer medications for people with a specific genetic trait called Duffy null phenotype. If you have multiple myeloma or triple negative breast cancer and have the Duffy null phenotype, you might be eligible. The study will test if using special dosing guidelines for medications like Dexamethasone, Bortezomib, Lenalidomide, Daratumumab, and Carboplatin can reduce or delay changes to your treatment and prevent neutropenic fever (a fever caused by a low number of white blood cells). Researchers will compare this to people without the Duffy null phenotype receiving standard care. The study aims to enroll 90 participants, but its current status is unclear.

Study design
This is a pilot study, meaning it's the first time these specific dosing guidelines are being tested. It involves two groups of participants and is designed to be practical, reflecting real-world treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Neutropenic fever will be assessed from the start of treatment through the end of protocol-based treatment, which is up to 6 or 8 cycles depending on your cancer type.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07341867

Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype

Recruiting
PHASE1Ages 18+InterventionalTreatment
Andrew Hantel, MD
~90 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:DexamethasoneBortezomibLENALIDOMIDEDaratumumabCarboplatinPaclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Avoided or reduced systemic anticancer therapy (SACT) modifications per cycle
Measured over Avoided or reduced modifications determined by ANC (anticancer therapy) values in each treatment cycle. Coh 1 (Dara-RVD) is 6 cycles(cycle=28 dys)-ANC assessed days 1, 8, 15, & 22. Coh 2 has 8 cycles (cycle=21 dys)-ANC assessed days 1, 8, & 15
+1 more outcome measured

Conditions

Multiple Myeloma
Triple Negative Breast Cancer
Duffy Blood Group, Chemokine Receptor Gene Mutation
Duffy Blood Group, Chemokine Receptor Gene C.-67T>C

Explore related trials

Multiple MyelomaTriple-negative breast cancerDuffy

NCT07341867

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrew Hantel, MD · PRINCIPAL_INVESTIGATOR · MD

Who to contact

Andrew Hantel, MD
[email protected]
617-582-9394
Email the study team

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Eligibility criteria

Inclusion

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.
Confirmed Duffy null phenotype
Previous testing is acceptable if performed by a CLIA-approved test
Age \>=18 years old

Exclusion

Inability to understand and the willingness to sign a written informed consent document
ANC\<500 within 7 days of planned start of Cycle 1 Day 1.
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
Another known condition or medicine with known impacts on neutrophil counts or neutrophil function

What this trial measures

  • Avoided or reduced systemic anticancer therapy (SACT) modifications per cycleAvoided or reduced modifications determined by ANC (anticancer therapy) values in each treatment cycle. Coh 1 (Dara-RVD) is 6 cycles(cycle=28 dys)-ANC assessed days 1, 8, 15, & 22. Coh 2 has 8 cycles (cycle=21 dys)-ANC assessed days 1, 8, & 15

    An ANC-related avoided or reduced SACT change is defined as an instance of no change in SACT dosing (by avoiding a dose hold, dose level change, or drug discontinuation) OR an instance of reduction in the SACT dose modification (through earlier resumption of therapy with or without avoidance of a dose modification in a subsequent cycle) using this study's Duffy null-specific parameters for ANC dose modifications compared to the dose modification that would have occurred according to the parameters used in PERSEUS (Dara-RVD) or Keynote 522 trials. For the primary outcome measure, an ANC-related avoided or reduced SACT change is measured on a per-cycle basis as a binary outcome.

  • Overall cumulative incidence of neutropenic feverNeutropenic fever is assessed from treatment initiation through the end of protocol-based treatment. It will be assessed at baseline and before treatment dosing during each cycle (Coh1 is 6 cycles (cycle=28 days); Coh 2 is 8 cycles (cycle=21 days)).

    Neutropenic fever is defined using modified CTCAE criteria. Grade 3 being defined as "ANC\<500/uL with a single temperature of \>38.3 C or a sustained temperature of \>38 for more than one hour"; and Grade 4 defined as "Life-threatening consequences; urgent intervention indicated". The cumulative incidence will be calculated as the number of participants with at least one documented occurrence of neutropenic fever, over the total number of participants enrolled.