Recruiting
Phase 1

Multiple Myeloma, Triple Negative Breast Cancer

Sponsor:

Andrew Hantel, MD

Code:

NCT07341867

Conditions

Multiple Myeloma

Triple Negative Breast Cancer

Duffy Blood Group, Chemokine Receptor Gene Mutation

Duffy Blood Group, Chemokine Receptor Gene C.-67T>C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Bortezomib

LENALIDOMIDE

Daratumumab

Carboplatin

Study Details

Brief summary:

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

Conditions

Multiple Myeloma

Triple Negative Breast Cancer

Duffy Blood Group, Chemokine Receptor Gene Mutation

Duffy Blood Group, Chemokine Receptor Gene C.-67T>C

Study ID

NCT07341867

Start date

Jul 30, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Dexamethasone

Tablet, taken orally

Bortezomib

Intravenous infusion

LENALIDOMIDE

Tablet, taken orally

Daratumumab

Intravenous infusion

Carboplatin

Intravenous infusion

Paclitaxel

Intravenous infusion

Pembrolizumab

Intravenous infusion

Cyclophosphamide

Intravenous infusion

Doxorubicin

Intravenous infusion

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 ]
  • Overall cumulative incidence of neutropenic fever [ Time Frame: 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)). ]

Central Contacts and Locations

Central contacts

Andrew Hantel, MD

617-582-9394andrew_hantel@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Andrew Hantel, MD

617-582-9394Andrew_hantel@dfci.harvard.edu

Principal Investigator:

Andrew Hantel, MD

More Information

Sponsor

Andrew Hantel, MD

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Duffy Null Phenotype
  • Multiple Myeloma
  • Triple Negative Breast Cancer
  • Dosing guidelines

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew Hantel, MD on 2026-08-17.