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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study is comprised of a main study, an observational study, and optional survey studies."
  • "The survey studies seek to understand general health experiences and preferences and experiences specific to people with Duffy null phenotype."
  • "The research study procedures include screening for eligibility, clinical exams-medical history/physical exam, study treatment, and surveys."
  • "Participants who elect to take part in the optional short surveys will complete the short surveys."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether special cancer drug dosing rules for adults with Duffy null status can reduce or delay dose changes and avoid fever when neutrophils, a type of white blood cell, are low. It is for people with multiple myeloma or triple-negative breast cancer. It also collects treatment data from people without Duffy null status and offers optional surveys about health experiences.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older.
  • Have confirmed Duffy null status. Past testing counts if it used a CLIA-approved lab test.
  • Have multiple myeloma, a blood cancer, that needs treatment, or stage II or III triple-negative breast cancer.
  • For multiple myeloma: plan to start, or are in the first treatment cycle of, daratumumab, lenalidomide, bortezomib, and dexamethasone.
  • For breast cancer: plan to start, or are in the first treatment cycle of, carboplatin, paclitaxel, and pembrolizumab before surgery. Later treatment plans may vary.

Who can't join

  • Cannot understand the study consent form or are not willing to sign it.
  • Have an absolute neutrophil count (ANC) below 500 within 7 days before the planned first treatment day. ANC measures a type of white blood cell.
  • Have already started the second treatment cycle.
  • For breast cancer: have received any of the later treatment portion involving pembrolizumab, doxorubicin, and cyclophosphamide.
  • Are receiving any other experimental drugs for any condition.
  • Have another known condition or take a medicine that affects neutrophil counts or how these cells work.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MA