NCT07341867 · Andrew Hantel, MD
Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype
What this study is about
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 the usual treatment 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
View original scientific description
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.
Interventions
DRUG
Dexamethasone
Tablet, taken orally
DRUG
Bortezomib
Intravenous infusion
DRUG
LENALIDOMIDE
Tablet, taken orally
DRUG
Daratumumab
Intravenous infusion
DRUG
Carboplatin
Intravenous infusion
DRUG
Paclitaxel
Intravenous infusion
DRUG
Pembrolizumab
Intravenous infusion
DRUG
Cyclophosphamide
Intravenous infusion
DRUG
Doxorubicin
Intravenous infusion
Primary outcome measures
Avoided or reduced systemic anticancer therapy (SACT) modifications per cycle
Time frame: 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
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 fever
Time frame: Neutropenic 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations