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A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies
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
Details
| Lead sponsor | Andrew Hantel, MD |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 90 |
| Start date | 2026-06 |
| Completion | 2029-03-31 |
Conditions
- Multiple Myeloma
- Triple Negative Breast Cancer
- Duffy Blood Group, Chemokine Receptor Gene Mutation
- Duffy Blood Group, Chemokine Receptor Gene C.-67T>C
Interventions
- Dexamethasone
- Bortezomib
- LENALIDOMIDE
- Daratumumab
- Carboplatin
- Paclitaxel
- Pembrolizumab
- Cyclophosphamide
- Doxorubicin
Primary outcomes
- Avoided or reduced systemic anticancer therapy (SACT) modifications per cycle — 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 — 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.
Countries
United States