Multiple MyelomaPhase 1NCT07341867
Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype
A Phase 1 study testing Dexamethasone, Bortezomib and LENALIDOMIDE in people with Multiple Myeloma and Triple Negative Breast Cancer, run by Andrew Hantel, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Triple Negative Breast Cancer, Duffy Blood Group, Chemokine Receptor Gene Mutation
- What is being tested?
- Dexamethasone, Bortezomib and LENALIDOMIDE
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2026to 31 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.***
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Andrew Hantel, MD, 617-582-9394, Andrew_hantel@dfci.harvard.edu
Andrew Hantel, MD
About this study
Official title: A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies
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
Read the detailed description
This research study is a parallel arm, pragmatic, pilot study. As a pilot study it will be the first time investigators are examining using Duffy null specific dose modification guidelines for treatment dosing for participants with multiple myeloma or triple negative breast cancer receiving treatment of:
- Daratumumab, lenalidomide, bortezomib and dexamethasone for multiple myeloma
- Paclitaxel, carboplatin, doxorubicin, cyclophosphamide, and pembrolizumab for triple negative breast cancer The study will also be looking to understand health experiences of participants with and without the Duffy null phenotype through optional observational and survey studies.
The U.S. Food and Drug Administration (FDA) has approved daratumumab, lenalidomide, bortezomib and dexamethasone as a treatment option for some individuals with multiple myeloma. This study uses these drugs in ways typically used in clinical practice but not in ways approved by the FDA. Specifically, the FDA approval does not approve the use of this treatment for more than 4 cycles prior to stem cell transplantation or in those who are deferring or ineligible for transplantation, or with the specific drug dosing used in this study. These unapproved modifications, however, are supported by treatment guidelines from the National Comprehensive Cancer Network.
The U.S. Food and Drug Administration (FDA) has approved paclitaxel, carboplatin, doxorubicin, cyclophosphamide, and pembrolizumab for preoperative treatment of triple negative breast cancer. This study uses these drugs in ways typically used in clinical practice but not in ways approved by the FDA. Specifically, the FDA approval does not approve the use of this treatment in individuals who have 1-10% ER or PR positivity (called low-level positivity). This population, however, is often treated as having ER or PR negative disease, and this treatment decision is noted as acceptable by the National Comprehensive Cancer Network.
The research study procedures include screening for eligibility, clinical exams-medical history/physical exam, study treatment, and surveys.
The study treatment for the multiple myeloma group will be Bortezomib, Daratumumab, Lenalidomide, and Dexamethasone given over a 28 day cycle for 6 cycles.
The study treatment for the triple negative breast cancer group will receive treatment in two phases.
- The first phase will be Paclitaxel, carboplatin, and pembrolizumab over a 21 day cycle for 4 cycles.
- The second phase will be doxorubicin, cyclophosphamide, and pembrolizumab over a 21 day cycle for 4 cycles.
Participants who elect to take part in the optional observational studies will provide use of medical records for comparison of Duffy null and non-Duffy null populations. Participants who elect to take part in the optional short surveys will complete the short surveys.
It is expected that about 90 people will take part in this research study, 60 in the treatment study, and 30 in the observational study.
The Principal Investigator of this study and Dana-Farber Cancer Institute are the primary sponsors of this study.
- Conditions
- Multiple Myeloma, Triple Negative Breast Cancer, Duffy Blood Group, Chemokine Receptor Gene Mutation, Duffy Blood Group, Chemokine Receptor Gene C.-67T>C
- Being tested
- Dexamethasone, Bortezomib, LENALIDOMIDE, Daratumumab, Carboplatin
- Keywords
- Duffy Null Phenotype, Multiple Myeloma, Triple Negative Breast Cancer, Dosing guidelines
- Medical subject headings
- Multiple Myeloma, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron, Dexamethasone Intensol, Dexasone, Solurex
Tablet, taken orally
BortezomibDrug
Also called Velcade
Intravenous infusion
LENALIDOMIDEDrug
Also called Revlimid
Tablet, taken orally
DaratumumabDrug
Also called Darzalex, Darzalex Faspro
Intravenous infusion
CarboplatinDrug
Also called Paraplatin
Intravenous infusion
PaclitaxelDrug
Also called Taxol
Intravenous infusion
PembrolizumabDrug
Also called Keytruda, Keytruda Qlex
Intravenous infusion
CyclophosphamideDrug
Also called Cytoxan
Intravenous infusion
DoxorubicinDrug
Also called Adriamycin, Rubex, Doxorubicin hydrochloride (HCl), Hydroxydaunorubicin
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Multiple myeloma (MM) | Experimental | 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 Receives: Drug: Dexamethasone; Drug: Bortezomib; Drug: LENALIDOMIDE; Drug: Daratumumab |
| Arm B: Triple-Neg Breast Cancer | Experimental | 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 Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab; Drug: Cyclophosphamide; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoided or reduced systemic anticancer therapy (SACT) modifications per cycle
An ANC-related avoided or reduced SACT change is defined as an instance of no change in SACT dosing (by avoiding a dose hold, dose level change, or drug discontinuation) OR an instance of reduction in the SACT dose modification (through earlier resumption of therapy with or without avoidance of a dose modification in a subsequent cycle) using this study's Duffy null-specific parameters for ANC dose modifications compared to the dose modification that would have occurred according to the parameters used in PERSEUS (Dara-RVD) or Keynote 522 trials. For the primary outcome measure, an ANC-related avoided or reduced SACT change is measured on a per-cycle basis as a binary outcome.
Measured: 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
Neutropenic fever is defined using modified CTCAE criteria. Grade 3 being defined as "ANC<500/uL with a single temperature of >38.3 C or a sustained temperature of >38 for more than one hour"; and Grade 4 defined as "Life-threatening consequences; urgent intervention indicated". The cumulative incidence will be calculated as the number of participants with at least one documented occurrence of neutropenic fever, over the total number of participants enrolled.
Measured: 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)).
Secondary outcomes (3)
Avoided or reduced systemic anticancer therapy (SACT) modifications per ANC check (i.e. per week)
An ANC-related avoided or reduced SACT change is defined as an instance of no change in SACT dosing (by avoiding a dose hold, dose level change, or drug discontinuation) OR an instance of reduction in the SACT dose modification (through earlier resumption of therapy with or without avoidance of a dose modification in a subsequent cycle) using this study's Duffy null-specific parameters for ANC dose modifications compared to the dose modification that would have occurred according to the parameters used in PERSEUS (Dara-RVD) or Keynote 522 trials. For the secondary outcome measure, an ANC-related avoided or reduced SACT change is measured on a per-ANC check basis as a binary outcome.
Measured: Avoided or reduced modifications determined by ANC (anticancer therapy) values during each treatment cycle. Coh1 (Dara-RVD) is 6 cycles(cycle=28 dys)- ANC assessed on days 1, 8, 15, & 22. Coh 2 is 8 cycles (cycle=21 dys)- ANC assessed days 1, 8, & 15
Cumulative incidence of neutropenic fever within regimen
Neutropenic fever is defined using modified CTCAE criteria. Grade 3 being defined as ""ANC<500/uL with a single temperature of >38.3 C or a sustained temperature of >38 for more than one hour""; and Grade 4 defined as ""Life-threatening consequences; urgent intervention indicated"". The cumulative incidence will be calculated as the number of participants with at least one documented occurrence of neutropenic fever, over the total number of participants enrolled in the regimen."
Measured: Neutropenic fever will be assessed from initiation of treatment through end of the last cycle of protocol-based treatment; cycle length and number varies by phase of therapy. It will be assessed at baseline and before therapy dosing during each cycle.
Relative dose intensity (RDI)
RDI will be calculated as the dose of the therapy administered divided by the dose as specified in the protocol. For multi-agent regimens, dose intensity will be calculated separately for each agent. Calculations will be done within patient.
Measured: Dosing, for the calculation of RDI, will be assessed immediately at the time of protocol-specified treatment from the initiation of treatment through treatment completion, an average of 6 months. Cycle and treatment length vary by treatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start30 Jul 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Hantel, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Hantel, MD, Dana-Farber Cancer Institute
- Investigators
- Andrew Hantel, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341867
- Sponsor's protocol ID
- 25-555
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: andrew\_hantel@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies
- ClinicalTrials.gov ID
- NCT07341867
- Acronym / sponsor ID
- 25-555
- Conditions
- Multiple Myeloma, Triple Negative Breast Cancer, Duffy Blood Group, Chemokine Receptor Gene Mutation, Duffy Blood Group, Chemokine Receptor Gene C.-67T>C
- Keywords
- Duffy Null Phenotype, Multiple Myeloma, Triple Negative Breast Cancer, Dosing guidelines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Andrew Hantel, MDUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This research study is a parallel arm, pragmatic, pilot study. As a pilot study it will be the first time investigators are examining using Duffy null specific dose modification guidelines for treatment dosing for participants with multiple myeloma or triple negative breast cancer receiving treatment of:
- Daratumumab, lenalidomide, bortezomib and dexamethasone for multiple myeloma
- Paclitaxel, carboplatin, doxorubicin, cyclophosphamide, and pembrolizumab for triple negative breast cancer The study will also be looking to understand health experiences of participants with and without the Duffy null phenotype through optional observational and survey studies.
The U.S. Food and Drug Administration (FDA) has approved daratumumab, lenalidomide, bortezomib and dexamethasone as a treatment option for some individuals with multiple myeloma. This study uses these drugs in ways typically used in clinical practice but not in ways approved by the FDA. Specifically, the FDA approval does not approve the use of this treatment for more than 4 cycles prior to stem cell transplantation or in those who are deferring or ineligible for transplantation, or with the specific drug dosing used in this study. These unapproved modifications, however, are supported by treatment guidelines from the National Comprehensive Cancer Network.
The U.S. Food and Drug Administration (FDA) has approved paclitaxel, carboplatin, doxorubicin, cyclophosphamide, and pembrolizumab for preoperative treatment of triple negative breast cancer. This study uses these drugs in ways typically used in clinical practice but not in ways approved by the FDA. Specifically, the FDA approval does not approve the use of this treatment in individuals who have 1-10% ER or PR positivity (called low-level positivity). This population, however, is often treated as having ER or PR negative disease, and this treatment decision is noted as acceptable by the National Comprehensive Cancer Network.
The research study procedures include screening for eligibility, clinical exams-medical history/physical exam, study treatment, and surveys.
The study treatment for the multiple myeloma group will be Bortezomib, Daratumumab, Lenalidomide, and Dexamethasone given over a 28 day cycle for 6 cycles.
The study treatment for the triple negative breast cancer group will receive treatment in two phases.
- The first phase will be Paclitaxel, carboplatin, and pembrolizumab over a 21 day cycle for 4 cycles.
- The second phase will be doxorubicin, cyclophosphamide, and pembrolizumab over a 21 day cycle for 4 cycles.
Participants who elect to take part in the optional observational studies will provide use of medical records for comparison of Duffy null and non-Duffy null populations. Participants who elect to take part in the optional short surveys will complete the short surveys.
It is expected that about 90 people will take part in this research study, 60 in the treatment study, and 30 in the observational study.
The Principal Investigator of this study and Dana-Farber Cancer Institute are the primary sponsors of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Multiple myeloma (MM) | Experimental | Drug: Dexamethasone, Drug: Bortezomib, Drug: LENALIDOMIDE, Drug: DaratumumabParticipants 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 |
| Arm B: Triple-Neg Breast Cancer | Experimental | Drug: Carboplatin, Drug: Paclitaxel, Drug: Pembrolizumab, Drug: Cyclophosphamide, Drug: DoxorubicinParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of:
- Plan for treatment, per their treating physician, or currently receiving their first cycle (see 3.3.3 for definition) of:
- AND
- Confirmed Duffy null phenotype
- AND
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Decadron, Dexamethasone Intensol, Dexasone, SolurexTablet, taken orally | Drug | Arm A: Multiple myeloma (MM) |
| BortezomibAlso: VelcadeIntravenous infusion | Drug | Arm A: Multiple myeloma (MM) |
| LENALIDOMIDEAlso: RevlimidTablet, taken orally | Drug | Arm A: Multiple myeloma (MM) |
| DaratumumabAlso: Darzalex, Darzalex FasproIntravenous infusion | Drug | Arm A: Multiple myeloma (MM) |
| CarboplatinAlso: ParaplatinIntravenous infusion | Drug | Arm B: Triple-Neg Breast Cancer |
| PaclitaxelAlso: TaxolIntravenous infusion | Drug | Arm B: Triple-Neg Breast Cancer |
| PembrolizumabAlso: Keytruda, Keytruda QlexIntravenous infusion | Drug | Arm B: Triple-Neg Breast Cancer |
| CyclophosphamideAlso: CytoxanIntravenous infusion | Drug | Arm B: Triple-Neg Breast Cancer |
| DoxorubicinAlso: Adriamycin, Rubex, Doxorubicin hydrochloride (HCl), HydroxydaunorubicinIntravenous infusion | Drug | Arm B: Triple-Neg Breast Cancer |
Primary outcome
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
An ANC-related avoided or reduced SACT change is defined as an instance of no change in SACT dosing (by avoiding a dose hold, dose level change, or drug discontinuation) OR an instance of reduction in the SACT dose modification (through earlier resumption of therapy with or without avoidance of a dose modification in a subsequent cycle) using this study's Duffy null-specific parameters for ANC dose modifications compared to the dose modification that would have occurred according to the parameters used in PERSEUS (Dara-RVD) or Keynote 522 trials. For the primary outcome measure, an ANC-related avoided or reduced SACT change is measured on a per-cycle basis as a binary outcome.
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)).
Neutropenic fever is defined using modified CTCAE criteria. Grade 3 being defined as "ANC<500/uL with a single temperature of >38.3 C or a sustained temperature of >38 for more than one hour"; and Grade 4 defined as "Life-threatening consequences; urgent intervention indicated". The cumulative incidence will be calculated as the number of participants with at least one documented occurrence of neutropenic fever, over the total number of participants enrolled.
3 secondary outcomes
Avoided or reduced systemic anticancer therapy (SACT) modifications per ANC check (i.e. per week)
Time frame: Avoided or reduced modifications determined by ANC (anticancer therapy) values during each treatment cycle. Coh1 (Dara-RVD) is 6 cycles(cycle=28 dys)- ANC assessed on days 1, 8, 15, & 22. Coh 2 is 8 cycles (cycle=21 dys)- ANC assessed days 1, 8, & 15
Cumulative incidence of neutropenic fever within regimen
Time frame: Neutropenic fever will be assessed from initiation of treatment through end of the last cycle of protocol-based treatment; cycle length and number varies by phase of therapy. It will be assessed at baseline and before therapy dosing during each cycle.
Relative dose intensity (RDI)
Time frame: Dosing, for the calculation of RDI, will be assessed immediately at the time of protocol-specified treatment from the initiation of treatment through treatment completion, an average of 6 months. Cycle and treatment length vary by treatment phase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: andrew_hantel@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Hantel, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone, Bortezomib and LENALIDOMIDE in people with Multiple Myeloma and Triple Negative Breast Cancer, run by Andrew Hantel, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Hantel, MD (617-582-9394, andrew_hantel@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.