Tests dose changes for cancer drugs in people with Duffy null blood type

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple myeloma or stage II or III triple negative breast cancer who have the Duffy null phenotype and are about to start, or just started, a set standard treatment.

Age

18 years or older

Sex

All sexes can join

Disease stage

Multiple myeloma that needs treatment (Cohort 1), or stage II or III triple negative breast cancer (Cohort 2).

Earlier treatment

Treatment is planned or is in the first cycle: Dara-RVd for multiple myeloma, or carboplatin, paclitaxel and pembrolizumab first for breast cancer. People who started Cycle 2 cannot join.

Biomarker or test result

Confirmed Duffy null phenotype. An earlier test is fine if a CLIA-approved test was used.

Main reasons for not taking part

• ANC below 500 within 7 days of planned start of Cycle 1 Day 1
• Already started Cycle 2 of therapy
• Breast cancer cohort: already had the pembrolizumab, doxorubicin and cyclophosphamide part of treatment
• Taking any other investigational agent
• Another condition or medicine known to affect neutrophil counts or function

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Arm A: Multiple myeloma (MM)Treatment being tested

  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

  Treatment: Dexamethasone, Bortezomib, LENALIDOMIDE, and Daratumumab

• Arm B: Triple-Neg Breast CancerTreatment being tested

  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

  Treatment: Carboplatin, Paclitaxel, Pembrolizumab, Cyclophosphamide, and Doxorubicin