BridgeMD
New treatment option for Multiple Myeloma
Official title Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
ClinicalTrials.gov ID: NCT04240054
What this study is testing
What is Bortezomib?
Bortezomib is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as Velcade.
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
- This is a single-arm, open-label phase II study with a safety lead-in phase.
- 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
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding...
- Male or female people ≥18 years.
- Patients must be eligible for high-dose therapy and autologous stem cell transplantation as per institutional guidelines.
- No prior multiple myeloma (MM) -directed therapy except for dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m\^2) and/or cyclophosphamide up...
- Patients must have documented multiple myeloma as defined by the criteria below (a, b, and c):
You likely can't join if
- For renal impaired Cohort A people, any subject who requires immediate treatment for management of renal failure (including, but not limited to...
- Diagnosed or treated for malignancy other than multiple myeloma, except:
- Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment or documentation that the malignancy...
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ (e.g., cervical, breast) with no evidence of disease.
- Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
See the full eligibility criteria
Who can join
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without...
- Male or female people ≥18 years.
- Patients must be eligible for high-dose therapy and autologous stem cell transplantation as per institutional guidelines.
- No prior multiple myeloma (MM) -directed therapy except for dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m\^2) and/or cyclophosphamide up to 500 mg/m\^2 administered for management of acute manifestations of...
- Patients must have documented multiple myeloma as defined by the criteria below (a, b, and c):
- Monoclonal plasma cells in the bone marrow of ≥10% or presence of a biopsy proven plasmacytoma AND
- Evidence of organ damage or myeloma-defining events (MDE) that can be attributed to the underlying proliferative plasma cell disorder (at least one of the following):
- Hypercalcemia: corrected serum calcium \>1 mg/dL higher than the upper limit of normal (ULN) or \>11 mg/Dl. OR
- Anemia: hemoglobin value of \>2.0 g/dL below the lower limit of normal, or a hemoglobin value \<10.0 g/dL. OR
- Bone marrow plasma cells of \>60%. OR
- Involved/uninvolved light chain ratio ≥100 OR
- Renal insufficiency: eGFR \< 40 mL/min/1.73m\^2 (based on the Modification of Diet in Renal Disease MDRD formula). [Cohort A people must meet this criterion.] If the patient is enrolled in the renal impaired (RI) A...
- Measurable disease as defined (at least one of the following):
- Serum M-protein level ≥0.5 g/dL; OR
- Urine M-protein level ≥200 mg/24 hours; OR
- Light chain multiple myeloma without measurable disease in the urine: serum immunoglobulin (Ig) free light chains (FLC) ≥10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Female people who:
- Are postmenopausal for at least one year before the screening visit, OR
- Are surgically sterile, OR
- Females of childbearing potential or male people with female partners of childbearing potential shall be required to use effective contraceptive methods (double barrier method, intrauterine device, oral contraception or...
- Established use of oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation.
- Established use of oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
- Placement of an intrauterine device or intrauterine hormone-releasing system.
- Barrier methods of contraception: male condom with either cap, diaphragm or sponge with spermicide (double-barrier methods). The use of double-barrier methods should always be supplemented with the use of a spermicide...
- Male sterilization (provided that the partner is the sole sexual partner of the patient and that the sterilized partner has received medical assessment of the surgical success).
- Sexual abstinence.
- Female people must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last...
- Male people, even if surgically sterilized (i.e., status postvasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through and through four months after the last dose of study drug(s) (female and...
- Agree to practice true abstinence during the entire study treatment period from the time of signing the informed consent through 16 weeks after the last dose of study drug(s), when this is in line with the preferred and...
What rules you out
- For renal impaired Cohort A people, any subject who requires immediate treatment for management of renal failure (including, but not limited to, dialysis). Such treatment is allowed once the patient becomes stable...
- Diagnosed or treated for malignancy other than multiple myeloma, except:
- Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment or documentation that the malignancy required/requires no treatment at time of enrollment.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ (e.g., cervical, breast) with no evidence of disease.
- Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
- Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have untreated or active hepatitis C.
- Concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for...
- Clinically significant cardiac disease, including:
- Myocardial infarction within six months before Cycle 1, Day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart...
- Uncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 5 Grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities.
- Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \>470 msec.
- Uncontrolled hypertension.
- Any of the following laboratory test results at the time of enrollment:
- Absolute neutrophil count \<1.0 × 109/L; no granulocyte colony stimulating factor (G-CSF) treatment in the past seven days are allowed.
- Hemoglobin level ≤7.5 g/dL (≤5 mmol/L); blood transfusions to maintain hemoglobin \>7.5 g/dL are acceptable.
- Platelet count \<75 × 109/L for people in whom \<50% of bone marrow nucleated cells are plasma cells; otherwise platelet count \<50 × 109/L; no platelet transfusions in the past seven days are allowed.
- Alanine aminotransferase (ALT) level ≥2.5 × ULN
- Aspartate aminotransferase (AST) level ≥2.5 × ULN
- Total bilirubin level ≥1.5 × ULN, (except for Gilbert Syndrome: direct bilirubin ≥2 × ULN)
- Known allergies, hypersensitivity (if not amenable to premedication with steroids, or H2 blockers), or intolerance to monoclonal antibodies or human proteins, isatuximab or its excipients or known sensitivity to...
- Plasma cell leukemia (\>2.0 × 10\^9/L circulating plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and/or skin...
- Known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder) or the subject has any condition for which, in the opinion of the...
- Pregnant or breastfeeding or planning to become pregnant starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
- Plans to father a child starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
- Had major surgery within two weeks before Cycle 1, Day 1, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within two weeks...
- Patients with pre-existing uncontrolled pulmonary disease will be excluded; uncontrolled refers to patients having had at least one hospitalization due to pulmonary disease (for example, asthma, chronic obstructive...
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, 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 Milwaukee, Wisconsin, United States. 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.