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New treatment option for Multiple Myeloma
Official title Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT05145400
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, given as an once-weekly 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
- This research study is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs.
- 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
- Subject Eligibility In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for...
- Willing and able to adhere to the study visit schedule and other protocol requirements based on the judgement of the investigator or protocol...
- Predicted high risk for severe toxicity from intensive induction regimens, such as standard (full-dose) Bortezomib, cyclophosphamide, dexamethasone...
- Score ≥ 2 (indicating "frail") on the International Myeloma Working Group instrument (IMWG; Palumbo et al. [Blood 2015]),
You likely can't join if
- Active infection requiring systemic antibiotics or other serious infection within 14 days prior to study treatment.
- people felt to not be candidates by treating physician for any systemic therapy due to excessive comorbidities, frailty, impaired performance status...
- Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the subject or may...
- Light-chain (AL) amyloidosis. people with secondary amyloidosis due to MM are eligible, if the amyloidosis is not felt to be a clinically significant...
- Myocardial infarction within 3 months prior to study treatment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled...
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
See the full eligibility criteria
Who can join
- Subject Eligibility In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (PHI). Consent must be obtained...
- Willing and able to adhere to the study visit schedule and other protocol requirements based on the judgement of the investigator or protocol designee.
- Predicted high risk for severe toxicity from intensive induction regimens, such as standard (full-dose) Bortezomib, cyclophosphamide, dexamethasone (VCD), lenalidomide, bortezomib, and dexamethasone (RVD), or...
- Score ≥ 2 (indicating "frail") on the International Myeloma Working Group instrument (IMWG; Palumbo et al. [Blood 2015]),
- Karnofsky Performance Status (KPS) ≤ 70,
- Felt not to be candidate for full-intensity induction by treating clinician due to comorbidities, performance status, or other factors not otherwise captured by the Palumbo system or performance status. The reason for...
- Measurable MM diagnosed according to the following standard criteria. Criteria A and B must be met, in addition to C and/or D:
- Monoclonal plasma cells in bone marrow ≥ 10% and/or presence of biopsy-proven plasmacytoma
- Monoclonal protein (M-protein) present in serum and/or urine, defined as serum M-protein of ≥ 1 g/dL (0.5 g/dL for Immunoglobulin A (IgA) MM) OR urine M-protein of ≥ 200 mg/24 hours. people lacking an M-protein meeting...
- One or more MM-related organ dysfunction findings such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) criteria listed below:
- Calcium elevation in blood (serum calcium 1 mg/dL ≥ upper limit of normal or \> 11 mg/dL)
- Renal insufficiency (creatinine clearance \ 2 mg/dL)
- Anemia (hemoglobin \< 10 g/dL or ≥ 2 g/dL below normal)
- Bone lesions (lytic bone lesions) on x-rays, computerized tomography (CT), Magnetic resonance imaging (MRI) or Positron emission tomography (PET)
- Myeloma-related biomarker of malignancy (1 or more should be fulfilled):
- ≥ 60% bone marrow plasmacytosis
- Serum involved / uninvolved free light chain ratio of ≥ 100, provided absolute level of involved light chain is at least 100 mg/L (10 mg/dL)
- More than one focal lesion on MRI ≥ 5 mm in size
- No prior systemic anti-myeloma therapy lasting more than 28 days (generally one cycle). Any prior therapy must be completed a minimum of 14 days before starting study drugs.
- people who require radiotherapy (which must be localized in its field size) may be treated during screening but initiating study therapy should be deferred until the radiotherapy is completed and 14 days have elapsed...
- Demonstrate adequate organ function and laboratory values as defined in below. Hematological
- Hemoglobin (Hgb) ≥ 8 g/dL Transfusion of packed red blood cells or use of erythropoietin or analogs is permitted, if clinically appropriate, to achieve this threshold.
- Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L Use of growth factors is permitted to fulfill this criterion, particularly if low ANC is felt to be due to MM by treating clinician. If low ANC is felt to be due to non-MM...
- Platelets ≥ 50 × 109/L if \< 50% of bone marrow nucleated cells are plasma cells, and
- ≥ 30 × 109/L if ≥ 50% of BM (Bone Marrow) nucleated cells are plasma cells.
- Platelet transfusions are permitted to reach entry criteria. If low platelets are felt to be due to non-MM causes, such as myelodysplasia or other bone marrow disorders unrelated to MM, then subject should not be...
- Calculated or measured glomerular filtration rate (GFR):Any GFR as long as not currently dialysis-dependent
- Females of childbearing potential (FCBP)\ must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and...
What rules you out
- Active infection requiring systemic antibiotics or other serious infection within 14 days prior to study treatment.
- people felt to not be candidates by treating physician for any systemic therapy due to excessive comorbidities, frailty, impaired performance status, or other severe limitations. Such limitations can be conceptualized...
- Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the subject or may interfere with compliance or interpretation of the study results.
- Light-chain (AL) amyloidosis. people with secondary amyloidosis due to MM are eligible, if the amyloidosis is not felt to be a clinically significant issue (e.g., amyloid found incidentally on bone marrow core biopsy...
- Myocardial infarction within 3 months prior to study treatment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or...
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the...
- Known gastrointestinal (GI) disease that could interfere with the oral absorption or tolerance of dexamethasone or lenalidomide including difficulty swallowing.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patients with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational...
- Receiving other investigational agents less than 14 days or 5 half-lives of first dose of therapy on this protocol, whichever is longer.
- Concurrent use of other anti-cancer agents or treatments with possible exception of agents with low likelihood of affecting outcome of this study, such as adjuvant hormonal therapy for remote history of breast cancer.
- Known to be HIV+ or have active infection with hepatitis A, B, or C; or tuberculosis.
- Chronic daily corticosteroids for other, non-MM-related medical conditions exceeding low-dose (e.g., prednisone ≥ 10 mg daily or equivalent).
- Subject is receiving prohibited medications or treatments as listed in the protocol that cannot be discontinued/replaced by an alternative therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Wilmington, North Carolina, United States
- Columbus, Ohio, 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 Chapel Hill, North Carolina, United States; Charlotte, North Carolina, United States; Durham, North Carolina, United States; Wilmington, North Carolina, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
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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.