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New treatment option for Multiple Myeloma
Official title A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
ClinicalTrials.gov ID: NCT06083922
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out whether cyclophosphamide, bortezomib, dexamethasone (CyBorD) with daratumumab SC is a safe treatment combination for MGRS-associated kidney disease including cast nephropathy associated with multiple myeloma. In addition, the researchers will find out whether the study drug combination is an effective treatment for these conditions.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for cast nephropathy associated with MM:
- people must have a confirmed diagnosis of NDMM as per standard IMWG criteria
- people must have measurable disease, defined as meeting at least 1 of the following criteria ≤ 14 days prior to registration:
- A monoclonal Immunoglobulin (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 0.5 g/dL.
- Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
You likely can't join if
- MGRS associated with diseases other than plasma cell dyscrasia (e.g. CLL, B-cell neoplasm, Waldenstrom's macroglobulinemia…)
- Plasma cell leukemia, AL amyloidosis, or POEMS syndrome.
- Treatment with prior drugs aimed at the plasma cell dyscrasia.
- Treatment with prior or concurrent investigational agents aimed at the plasma cell dyscrasia.
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery ≤ 14 days before registration.
See the full eligibility criteria
Who can join
- for cast nephropathy associated with MM:
- people must have a confirmed diagnosis of NDMM as per standard IMWG criteria
- people must have measurable disease, defined as meeting at least 1 of the following criteria ≤ 14 days prior to registration:
- A monoclonal Immunoglobulin (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 0.5 g/dL.
- Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
- Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
- eGFR must be \<40 ml/min/1.73m2
- people must have histologically confirmed diagnosis of monoclonal gammopathy associated CN by kidney biopsy OR If a kidney biopsy is not available, a percentage of urine albumin excretion (%UAE) \ 50 mg/dL for other...
- Histologically confirmed diagnosis of MGRS-associated renal disease by kidney biopsy
- Presence of monoclonal gammopathy by serum protein electrophoresis, Immunofixation, or Free Light Chain Assay
- Evidence of plasma cell dyscrasia by bone marrow biopsy confirming clonal plasma cell population
- eGFR \ 1gm for both cast nephropathy associated with MM and other MGRS associated renal diseases
- people must be ≥ 18 years of age at time of registration.
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 ≤ 14 days prior to registration.
- No evidence of unequivocal recent nephrotoxic exposure (NSAIDs, radiocontrast…)
- No evidence of obstructive nephropathy by ultrasound
- people must have adequate hematology laboratory values within 14 days prior to registration defined by the following:
- Neutrophils ≥ 1.0 × 10\^9 /L (Patients cannot have received G-CSF or GM-CSF within 1 week of screening or pegfilgrastim within 2 weeks of screening to meet eligibility).
- Platelets ≥ 100 × 10\^9 /L for run-in and 75 × 10\^9 /L for phase II (Note: Platelet support is not permitted to help participants meet eligibility criteria).
- hemoglobin ≥ 7.5 g/dL without prior red blood cells [RBC] transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted.
- people must have adequate hepatic function laboratory values ≤ 14 days prior to registration:
- Aspartate aminotransferase (AST), alkaline phosphatase (AP) or alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN except for patients with a history of elevated total bilirubin, such as in Gilbert's.
- Hepatic Child-Pugh score at worse A (patients are eligible for the phase 2 part but not for the Run-in-Period of the trial).
- Female patients will have to satisfy the following criteria:
- Be postmenopausal for at least 1 year Prior to registration visit, OR
- Be surgically sterile, OR
- If of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are...
- Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following
- Practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Practice true abstinence when this is in line with the preferred and usual lifestyle of he subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not...
- people must have the willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, study procedures, and research procedures.
What rules you out
- MGRS associated with diseases other than plasma cell dyscrasia (e.g. CLL, B-cell neoplasm, Waldenstrom's macroglobulinemia…)
- Plasma cell leukemia, AL amyloidosis, or POEMS syndrome.
- Treatment with prior drugs aimed at the plasma cell dyscrasia.
- Treatment with prior or concurrent investigational agents aimed at the plasma cell dyscrasia.
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery ≤ 14 days before registration.
- Focal radiation therapy within 14 days prior to registration with the exception of palliative- radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.
- Disease-related central nervous system involvement.
- The subject has uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection.
- Clinically significant cardiac disease, including:
- Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart...
- Uncontrolled cardiac arrhythmia
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Concurrent malignancy except for treated non-melanoma skin cancer, cervical carcinoma in situ and low-risk prostate CA being monitored without treatment.
- Grade 2 or higher peripheral neuropathy on clinical examination during the screening period.
- Chemotherapy ≤ 14 days of registration.
- Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic halflives, whichever is longer.
- Patients with known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal; moderate or severe persistent asthma within the past 2 years. Note that FEV1...
- Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma...
- Patients who have a contraindication to the use of any form of anticoagulation or antiplatelet agents.
- The use of strong CYP3A4 and CYP1A2 inducers or inhibitors will not be allowed while patients are treated on this study.
- Patients with Hepatic Child-Pugh score B and C. Note that patients with Hepatic Child-Pugh score A are excluded from the Run-in-Period of the trial
- Patient is:
- Known history of human immunodeficiency virus (HIV) and those who are seropositive for HIV.
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). people with resolved infection (ie, people who are HBsAg negative but positive for antibodies to hepatitis B core...
- Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
- Vaccination with live attenuated vaccines within 4 weeks of first study agent administration.
- Plasmapheresis within 28 days before randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.