Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07341867
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07341867
Study Brief:
Protocol Section:
NCT07341867