💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein \< 3 gm/dL and bone marrow plasma cells \< 10% plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible.
3.1.4 Patient must have newly diagnosed (within the last 90 days) light chain cast nephropathy (LCCN) defined as patients with \>1 g/dl proteinuria with \<10% albuminuria, and/or an involved serum free light chain (FLC) concentration \>150 mg/dL.
3.1.5 Patient must have new onset of renal failure (within the last 90 days). Patient must have met one of the following criteria:
* Any serum creatinine who have an eGFR of \<40 ml/min/1.73 m2 calculated with the Modification of Diet in Renal Disease (MDRD) formula
* Serum creatinine \>2 mg/dL
* On dialysis NOTE: eGFR must be \< 50 ml/min/1.73 m2 if eligible based on serum creatinine level and/or dialysis.
NOTE: The MDRD formula38 (mL/min/1.73 m2) = GFR = 175 x SCr-1.154 × age-0.203 × 0.742 (if female) × 1.212 (if black) SCr: \_\_\_\_\_\_\_\_ Date of Test: \_\_\_\_\_\_\_\_\_\_\_\_\_ GFR: \_\_\_\_\_ (mL/min/1.73 m2) Date of calculation: \_\_\_\_\_\_\_\_ 3.1.6 Patient may have received myeloma targeting therapy including any of the following: cyclophosphamide, bortezomib and/or dexamethasone, as long as it was no more than one cycle AND the last dose administered was within 30 days prior to randomization.
NOTE: There is no washout period required. 3.1.7 Patient may have received plasma exchange to treat LCCN within 30 days prior to randomization.
3.1.8 Patient must not have been exposed to any prior or currently be on any anti-CD38 monoclonal antibodies.
3.1.9 Patients who have received prior investigational drug (including investigational vaccine) or invasive investigational medical device for any indication must have recovered from clinically significant adverse events prior to randomization.
3.1.10 Patient must not have current or prior exposure to focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.
3.1.11 Patient must have SPEP, UPEP, and serum FLC assays performed within 28 days prior to randomization. In addition, a bone marrow biopsy and/or aspirate and/or tissue biopsy of any bone lesion or extramedullary plasmacytoma is required to be performed within 28 days prior to randomization.
Serum M-protein by SPEP: \_\_\_\_\_\_\_ (g/dL) Date of SPEP test:\_\_\_\_\_\_\_ Urine M-protein by 24 hr UPEP: \_\_\_\_\_\_\_ (mg/24 hr) Date of UPEP test:\_\_\_\_\_\_\_ NOTE: UPEP (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hr. If both serum and urine M-components are measurable, both must be followed in order to confirm response.
Serum Free Light Chain Assay Date of Light Chain Assay test:\_\_\_\_\_\_\_ Kappa FLC:\_\_\_\_\_\_\_ (mg/dL) or \_\_\_\_\_\_\_ (mg/L) Lambda FLC:\_\_\_\_\_\_\_ (mg/dL) or \_\_\_\_\_\_\_ (mg/L) Kappa/lambda ratio:\_\_\_\_\_\_\_ NOTE: The serum free light chain test is required to be done monthly if the patient does not have measurable disease in the serum or urine.
3.1.12 Patient must have adequate bone marrow function as defined below (these labs must be obtained \< 28 days prior to randomization): Hemoglobin ≥ 7.5 g/dL (≥ 4.65 mmol/L). Use of prior red blood cell (RBC) transfusion or recombinant human erythropoietin use is permitted.
Hgb: \_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Absolute Neutrophil Count (ANC) \> 1000 mcL ANC:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Platelets \> 75,000 mcL. Prior platelet transfusion is permitted. Platelets:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ 3.1.13 Patient must have adequate hepatic function as defined below (these labs must be obtained ≤ 28 days prior to randomization): Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) Total Bilirubin:\_\_\_\_\_\_\_\_\_\_ Institutional ULN:\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ AST(SGOT) and ALT(SGPT) ≤ 3 × institutional ULN AST:\_\_\_\_\_\_\_ Institutional ULN:\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_ ALT: \_\_\_\_\_\_\_Institutional ULN:\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_ 3.1.14 Patient must not be pregnant or breast-feeding due to the potential harm to an unbo
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What it tests
- Cyclophosphamide
- Bortezomib (VELCADE)
- Dexamethasone
- Daratumumab-hyaluronidase
Alaska Oncology and Hematology LLC
Anchorage, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.