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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndrew Hantel, MD

About this trial

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

Eligibility criteria

Qualifiers

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

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.***

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dexamethasone
  • Bortezomib
  • LENALIDOMIDE
  • Daratumumab
  • Carboplatin
  • Paclitaxel
  • Pembrolizumab
  • Cyclophosphamide
  • Doxorubicin

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Andrew Hantel, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution