Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compa… (NCT07085728) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure
United States74 participantsStarted 2025-08-11
Plain-language summary
This study is being done to answer the following question:
Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because the investigators want to find out if this approach is better or worse than the usual approach for the participant's newly diagnosed multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
If the participant decides to take part in this study, they will either get the study medications daratumumab-hyaluronidase, bortezomib, and dexamethasone for four months (4 cycles), or the typical medications used to treat your cancer (cyclophosphamide, bortezomib, and dexamethasone) for 4 months (4 cycles).
After the participant finishes their study treatment, their doctor will continue to follow their condition for 10 years to watch them for side effects and monitor their disease status. Their doctor will follow up with them every 3 months for years 1 and 2 and then every 6 months for years 3 through 10.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
3.1.1 Patient must be ≥ 18 years of age. 3.1.2 Patient must have an ECOG Performance Status 0-2. NOTE: ECOG Performance Status 3 patients are eligible if attributable to pathological fractures and/or cancer-related bone pain.
3.1.3 Patient must have multiple myeloma and meet BOTH of the following criteria for the original diagnosis of myeloma following the International Myeloma Working Group (IMWG) myeloma diagnostic criteria within 90 days prior to randomization.
1. Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma.
Plasma cell % on Bone Marrow \_\_\_\_\_\_ (%) Date of test:\_\_\_\_\_\_\_ Tissue biopsy of any bone lesion or extramedullary plasmacytoma if applicable (Positive / Negative for Clonal Plasma Cells) Date of test:\_\_\_\_\_\_\_
2. Any one or more of the following myeloma-defining events:
* Anemia (hemoglobin value of \>2 g/dL below the lower limit of normal, or a hemoglobin value \<10 g/dL)
* Hypercalcemia (serum calcium \>1 mg/dL higher than the upper limit of normal or \>11 mg/dL)
* Bone disease (one or more osteolytic lesions on skeletal radiography, CT, or FDG-PET/CT)
* Renal dysfunction (creatinine clearance \< 40 mL/min or serum creatinine \>2 mg/dL).
* Clonal BMPCs ≥60%
* Involved: uninvolved serum free light chain ratio ≥100
* \> 1 focal lesions on MRI studies ≥5 mm NOTE: Patients with smoldering myeloma (serum m protein ≥ 3 gm/dL or bone marrow plasma cells ≥ 10% plus no ev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Renal Response Rate
Timeframe: Assessed every cycle on treatment up to 4 cycles (cycle duration=28 days)