What this study is
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
What's being tested
- Dexamethasone
Intervention · DRUG
- Bortezomib
Intervention · DRUG
- LENALIDOMIDE
Intervention · DRUG
- Daratumumab
Intervention · DRUG
- Carboplatin
Intervention · DRUG
- Paclitaxel
Intervention · DRUG
- Pembrolizumab
Intervention · DRUG
- Cyclophosphamide
Intervention · DRUG
- Doxorubicin
Intervention · DRUG
Both Dexamethasone and LENALIDOMIDE
Tablet, taken orally
All of Bortezomib, Daratumumab, Carboplatin, Paclitaxel, Pembrolizumab, Cyclophosphamide, Doxorubicin
Intravenous infusion
Study details
- Official title
- A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies
- Sponsor
- Andrew Hantel, MD
- Conditions
- Multiple Myeloma · Triple Negative Breast Cancer · Duffy Blood Group, Chemokine Receptor Gene Mutation · Duffy Blood Group, Chemokine Receptor Gene C.-67T>C
- Enrolling
- 90 people
- Starts
- 2026-07-30
- Est. completion
- 2029-03-31
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openDana-Farber Cancer Institute
Boston, Massachusetts, United States
- Andrew Hantel, MD · Contact617-582-9394Andrew_hantel@dfci.harvard.edu
- Andrew Hantel, MD · Principal investigator
RecruitingThe Christ Hospital Cancer Center-Research
Cincinnati, Ohio, United States
- Julie Specht, MD · Contact513-321-4333julie.specht@thechristhospital.com
- Julie Specht, MD · Principal investigator
Not yet recruiting
Study team
Sponsor
Andrew Hantel, MD
Study ID 25-555
Principal investigator
Andrew Hantel, MD
MD
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.