Dose Modifications for Multiple Myeloma and Breast Cancer

Overseen By Andrew Hantel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Andrew Hantel, MD

Must be taking: Dara-RVd, Keynote 522

Must not be taking: Investigational agents

Disqualifiers: Informed consent, ANC<500, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Andrew Hantel, MD

Principal Investigator

MD

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Duffy null phenotype who need treatment for multiple myeloma or stage II/III triple negative breast cancer. It includes those on specific chemotherapy regimens, even if treatments extend beyond initial cycles or vary from the planned drugs.

Inclusion Criteria

I have multiple myeloma needing treatment.

My condition is Stage II or III triple-negative breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment - Multiple Myeloma

Participants with Multiple Myeloma receive Bortezomib, Daratumumab, Lenalidomide, and Dexamethasone over a 28-day cycle for 6 cycles

24 weeks

Weekly visits for drug administration

Treatment - Triple Negative Breast Cancer

Participants with Triple Negative Breast Cancer receive Paclitaxel, Carboplatin, and Pembrolizumab for 4 cycles, followed by Doxorubicin, Cyclophosphamide, and Pembrolizumab for another 4 cycles

24 weeks

Weekly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Optional Observational and Survey Studies

Participants may opt into observational studies and complete surveys to compare health experiences between Duffy null and non-Duffy null populations

What Are the Treatments Tested in This Trial?

Interventions

• Bortezomib
• Carboplatin
• Cyclophosphamide
• Daratumumab
• Dexamethasone
• Doxorubicin
• Lenalidomide
• Paclitaxel
• Pembrolizumab

Trial Overview

The study tests whether tailored dosing guidelines for individuals with Duffy null phenotype can reduce dose changes and prevent fever due to low neutrophils during treatment. It compares these outcomes to patients without this phenotype receiving standard care.

How Is the Trial Designed?

Group I: Arm B: Triple-Neg Breast Cancer Experimental Treatment 5 Interventions

Participants with Triple Negative Breast Cancer and identified Duffy Null phenotype will receive standard of care (Keynote-522) per institutional protocol with dosage adjustments per Duffy-Null guidance Study treatment cycle lasts 21 days * Pembrolizumab 1x every 21 days on day 1 for cycles 1-4 * Paclitaxel 1x weekly on D1, 8, and 15 for cycles 1-4 * Carboplatin 1x weekly on D1, 8, and 15 for cycles 1-4 * Doxorubicin 1x every 14 days for cycles 5-8 * Cyclophosphamide 1x every 14 days for cycles 5-8 * Pembrolizumab 1x every 21 days on day 1 for cycles 5-8

Group II: Arm A: Multiple myeloma (MM) Experimental Treatment 4 Interventions

Participants with Multiple Myeloma and identified Duffy Null phenotype will receive standard of care (Dara-RVD) per institutional protocol with dosage adjustments per Duffy-Null guidance. Study treatment cycle lasts 28 days * dexamethasone 1X daily on days 1, 2, 8, 9, 15, 16, 22, 23 for 6 cycles * lenalidomide 1x daily on days 1-21 for 6 cycles * bortezomib 1x weekly for 2 cycles * daratumumab 1x weekly up to 2 cycles, then every 14 days for 4 more cycles

Who Is Running the Clinical Trial?

Andrew Hantel, MD

Lead Sponsor