Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype

Conditions

• Duffy Blood Group, Chemokine Receptor Gene C.-67T>C
• Duffy Blood Group, Chemokine Receptor Gene Mutation
• Multiple Myeloma
• Triple Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dexamethasone — DRUG
  Tablet, taken orally
• Bortezomib — DRUG
  Intravenous infusion
• LENALIDOMIDE — DRUG
  Tablet, taken orally
• Daratumumab — DRUG
  Intravenous infusion
• Carboplatin — DRUG
  Intravenous infusion
• Paclitaxel — DRUG
  Intravenous infusion
• Pembrolizumab — DRUG
  Intravenous infusion
• Cyclophosphamide — DRUG
  Intravenous infusion
• Doxorubicin — DRUG
  Intravenous infusion

Study Details

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

Key Dates

Start date

Jun 30, 2026

Status verified

Jan 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Multiple myeloma (MM)
  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
• Experimental: Arm B: Triple-Neg Breast Cancer
  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

Primary Outcome Measure

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 ]

Central Contacts

• Andrew Hantel, MD
  617-582-9394
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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