Multiple MyelomaEarly Phase 1NCT06142396
Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
A Early Phase 1 study testing Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone in people with Multiple Myeloma and Renal Failure, run by Augusta University at 1 site in United States.
Trial summary
The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma, Renal Failure
- What is being tested?
- Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Nov 2027
- Phase
- Early 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.
- Patients must have Zubrod/ECOG Performance Status ≤ 2.
- Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl < 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or necessitating dialysis
- must not have known allergies to any of the study drugs. Must have adequate organ function.
- International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
Who cannot join
- 1. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
- 2. Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
- 4. Known Clinically significant heart disease is defined as: myocardial infarction within 6 months before enrollment, or unstable or uncontrolled disease/condition related to or affection cardiac function.
- 5. Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.
- 6. Patients with grade 3 or 4 peripheral neuropathy 7. Patients with other active malignancies that require concurrent treatment 8. Known CNS involvement or plasma cell leukemia, or AL amyloidosis 9. Participants with active infection requiring systemic therapy 10. Has known substance abuse disorders that would interfere with cooperation with the requirements of the study.
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
Georgia Cancer Center-Augusta University
Augusta, Georgia, 30912
Amany RA Keruakous, MD, 7067212505, AKERUAKOUS@augusta.edu
James T Sonnenberg, BS, 9106192597, jsonnenberg@augusta.edu
About this study
Official title: Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients.
The primary questions this study aims to answer are:
- To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord.
- To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.
Read the detailed description
Acute renal impairment (RI) is a myeloma emergency. Diagnosis should be established as fast as possible, and antimyeloma therapy should be started immediately after confirmation of the diagnosis to restore renal function rapidly. The incidence of RI at diagnosis ranges from 20% to 50%. Patients with RI had more advanced disease than the others, a lower response rate to treatment than those with normal renal function, and shorter survival. Overall survival is significantly longer among those with baseline CrCl ≥30 mL per minute than those with CrCl <30 mL per minute.
This is a prospective, interventional pilot study for patients with newly diagnosed multiple myeloma (NDMM) who have new onset renal failure. The study will implement a planned enrollment strategy to focus on the African American (AA) patient population, with an accrual goal of 50% of all participants. All participants will be assigned to receive induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles of 28 days, followed by restaging with repeat PET-CT, bone marrow evaluation, and myeloma serological testing. After induction with Dara-CyBorD, further treatment as per standard guidelines will be determined at the physician's discretion based on transplant eligibility to either an additional 2 cycles of Dara-CyBorD followed by maintenance therapy (if transplant ineligible) or autologous stem cell transplantation (ASCT) followed by maintenance therapy (if transplant eligible). Maintenance therapy will consist of lenalidomide with dara SC for 2 years. Participants will be followed every three months for up to 2 years per the standard guidelines or until disease progression or the start of a new line of therapy to assess the duration of response.
The use of novel antimyeloma agents resulted in a substantial increase in the survival of patients with MM with RI. MM patients with RI are generally excluded from clinical trials. Clinical trials for MM patients with RI are an unmet need. Bortezomib-based regimens remain the cornerstone of the management of myeloma-related RI, with high-dose dexamethasone, with the addition of a conventional chemotherapy agent (cyclophosphamide).
- Conditions
- Multiple Myeloma, Renal Failure
- Being tested
- Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone
- Keywords
- Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and DexamethasoneCombination product
Also called DaraCyBord
This intervention is Daratumumab-hyaluronidase in combination with the chemotherapy regimen "CyBord" (cyclophosphamide, bortezomib, and dexamethasone) and then with lenalidomide maintenance in patients with newly diagnosed multiple myeloma who have new onset renal failure.
| Study group | Role | What they receive |
|---|---|---|
| Dara-CyBorD | Experimental | Induction treatment with daratumumab-hyaluronidase (dara SC) in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles of 28 days, followed by restaging with repeat PET-CT, bone marrow evaluation, and myeloma serological testing. Receives: Combination Product: Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
VGPR
Very good partial response rate (VGPR) or better after 4 cycles of Dara-CyBorD
Measured: 4 months
Renal Response Rate (RRR)
Renal response rate (RRR, defined as > 30% improvement in creatinine clearance - CrCl from baseline at the point of study entry) after 4 cycles of Dara-CyBorD
Measured: 4 months
Secondary outcomes (6)
Overall response rate (ORR)
Overall response rate (ORR) after 4 cycles of Dara-CyBorD
Measured: 4 months
VGPR, CR, & MRD
Proportion of patients achieving VGPR, CR, and measurable residual disease negativity <10-5 (MRD-), if applicable, after 4 cycles of Dara-CyBorD
Measured: 4 months
Duration of response (DOR)
Duration of response (DOR), defined from the date response achieved to the date of disease relapse
Measured: 2 years
Time to renal response
Time to renal response, defined as the number of days from starting treatment to >30% improvement of CrCl from CrCl at study entry or achieving dialysis independence
Measured: 2 years
Dialysis independence
Proportion of participants who achieved dialysis independence after four cycles of Dara-CyBorD
Measured: 4 months
autologous stem cell transplantation (ASCT)
Proportion of patients undergoing autologous stem cell transplantation (ASCT) after 4 cycles of Dara-CyBorD induction
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Nov 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study for combination medication treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Amany RA Keruakous, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142396
- Sponsor's protocol ID
- 54767414MMY2095
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
- ClinicalTrials.gov ID
- NCT06142396
- Acronym / sponsor ID
- 54767414MMY2095
- Conditions
- Multiple Myeloma, Renal Failure
- Keywords
- Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Nov 2023 (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.
The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients.
The primary questions this study aims to answer are:
- To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord.
- To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.
Detailed description
Acute renal impairment (RI) is a myeloma emergency. Diagnosis should be established as fast as possible, and antimyeloma therapy should be started immediately after confirmation of the diagnosis to restore renal function rapidly. The incidence of RI at diagnosis ranges from 20% to 50%. Patients with RI had more advanced disease than the others, a lower response rate to treatment than those with normal renal function, and shorter survival. Overall survival is significantly longer among those with baseline CrCl ≥30 mL per minute than those with CrCl <30 mL per minute.
This is a prospective, interventional pilot study for patients with newly diagnosed multiple myeloma (NDMM) who have new onset renal failure. The study will implement a planned enrollment strategy to focus on the African American (AA) patient population, with an accrual goal of 50% of all participants. All participants will be assigned to receive induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles of 28 days, followed by restaging with repeat PET-CT, bone marrow evaluation, and myeloma serological testing. After induction with Dara-CyBorD, further treatment as per standard guidelines will be determined at the physician's discretion based on transplant eligibility to either an additional 2 cycles of Dara-CyBorD followed by maintenance therapy (if transplant ineligible) or autologous stem cell transplantation (ASCT) followed by maintenance therapy (if transplant eligible). Maintenance therapy will consist of lenalidomide with dara SC for 2 years. Participants will be followed every three months for up to 2 years per the standard guidelines or until disease progression or the start of a new line of therapy to assess the duration of response.
The use of novel antimyeloma agents resulted in a substantial increase in the survival of patients with MM with RI. MM patients with RI are generally excluded from clinical trials. Clinical trials for MM patients with RI are an unmet need. Bortezomib-based regimens remain the cornerstone of the management of myeloma-related RI, with high-dose dexamethasone, with the addition of a conventional chemotherapy agent (cyclophosphamide).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study for combination medication treatment.
| Arm | Type | Receives |
|---|---|---|
| Dara-CyBorD | Experimental | Combination Product: Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and DexamethasoneInduction treatment with daratumumab-hyaluronidase (dara SC) in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles of 28 days, followed by restaging with repeat PET-CT, bone marrow evaluation, and myeloma serological testing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.
- Patients must have Zubrod/ECOG Performance Status ≤ 2.
- Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl < 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or necessitating dialysis
- must not have known allergies to any of the study drugs. Must have adequate organ function.
- International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
Key exclusion criteria (5 listed)
- 1. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
- 2. Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
- 4. Known Clinically significant heart disease is defined as: myocardial infarction within 6 months before enrollment, or unstable or uncontrolled disease/condition related to or affection cardiac function.
- 5. Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.
- 6. Patients with grade 3 or 4 peripheral neuropathy 7. Patients with other active malignancies that require concurrent treatment 8. Known CNS involvement or plasma cell leukemia, or AL amyloidosis 9. Participants with active infection requiring systemic therapy 10. Has known substance abuse disorders that would interfere with cooperation with the requirements of the study.
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 |
|---|---|---|
| Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and DexamethasoneAlso: DaraCyBordThis intervention is Daratumumab-hyaluronidase in combination with the chemotherapy regimen "CyBord" (cyclophosphamide, bortezomib, and dexamethasone) and then with lenalidomide maintenance in patients with newly diagnosed multiple myeloma who have new onset renal failure. | Combination product | Dara-CyBorD |
Primary outcome
VGPR
Time frame: 4 months
Very good partial response rate (VGPR) or better after 4 cycles of Dara-CyBorD
Renal Response Rate (RRR)
Time frame: 4 months
Renal response rate (RRR, defined as > 30% improvement in creatinine clearance - CrCl from baseline at the point of study entry) after 4 cycles of Dara-CyBorD
6 secondary outcomes
Overall response rate (ORR)
Time frame: 4 months
VGPR, CR, & MRD
Time frame: 4 months
Duration of response (DOR)
Time frame: 2 years
Time to renal response
Time frame: 2 years
Dialysis independence
Time frame: 4 months
autologous stem cell transplantation (ASCT)
Time frame: 4 months
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 12 Mar 2026.
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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.
Amany RA Keruakous, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone in people with Multiple Myeloma and Renal Failure, run by Augusta University 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 5 inclusion and 5 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 12 Mar 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Amany RA Keruakous, MD (706-721-2505, AKERUAKOUS@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VGPR (time frame: 4 months). 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 12 Mar 2026.