No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Andrew Hantel, MD · Other
Who this trial is looking for
This trial is looking for people with a specific genetic trait called Duffy null who are being treated for multiple myeloma or triple negative breast cancer. Participants will receive certain cancer medications while the study monitors their treatment and any side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with multiple myeloma or triple negative breast cancer.
I am currently receiving treatment or planning to start treatment.
I have a confirmed Duffy null phenotype.
I am 18 years old or older.
You may not be able to join if
I cannot understand and sign a consent form.
My neutrophil count is below 500.
I have already started my second cycle of treatment.
I have received specific other medications before joining this trial.
I am taking any other investigational drugs.
I have another condition or medication affecting my neutrophils.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 br…
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
Trial Locations
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City
State
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Status
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.…
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
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