A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies
Andrew Hantel, MD
Summary
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
Description
This research study is a parallel arm, pragmatic, pilot study. As a pilot study it will be the first time investigators are examining using Duffy null specific dose modification guidelines for treatment dosing for participants with multiple myeloma or triple negative breast cancer receiving treatment of: * Daratumumab, lenalidomide, bortezomib and dexamethasone for multiple myeloma * Paclitaxel, carboplatin, doxorubicin, cyclophosphamide, and pembrolizumab for triple negative breast cancer The study will also be looking to understand health experiences of participants with and without the Duf…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 beyo…
Interventions
- DrugDexamethasone
Tablet, taken orally
- DrugBortezomib
Intravenous infusion
- DrugLENALIDOMIDE
Tablet, taken orally
- DrugDaratumumab
Intravenous infusion
- DrugCarboplatin
Intravenous infusion
- DrugPaclitaxel
Intravenous infusion
- DrugPembrolizumab
Intravenous infusion
Location
- Dana-Farber Cancer InstituteBoston, Massachusetts