Dose-modified cancer therapy for people with Duffy null phenotype

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a parallel-arm, pragmatic pilot study that explores dose-modification guidelines tailored to the Duffy null phenotype. It includes a main study comparing standard dosing to Duffy null-guided dosing in patients with multiple myeloma or TNBC, plus observational and optional survey components to understand outcomes and patient experiences. Participants will receive regimens commonly used in practice, including daratumumab-based therapy for myeloma and a carboplatin-paclitaxel-pembrolizumab approach for TNBC, with dosing adjustments guided by phenotype status. The study aims to see if phenotype-guided dosing can reduce dose modifications and neutropenic fever without compromising treatment intent. FDA-approved uses of the involved drugs are acknowledged, but the specific Duffy null dosing modifications are investigational and guided by protocol-based guidelines.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• The Christ Hospital Cancer Center-Research
  Cincinnati, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Andrew Hantel, MD — Md
• Study coordinator: Andrew Hantel, MD
• Email: andrew_hantel@dfci.harvard.edu
• Phone: 617-582-9394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.