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New treatment option for Multiple Myeloma
Official title Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
ClinicalTrials.gov ID: NCT05344833
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, given as an infusion into a vein, 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 is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
- 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
- NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy)...
- Age \> 18 years
- Patients must have a confirmed diagnosis of multiple myeloma according to IMWG criteria. Patients with smoldering multiple myeloma, or plasma cell...
- R-ISS stage 1, 2 or 3 at diagnosis. If stage at diagnosis is not known, patient may be enrolled if the intent is to treat with post -ASCT maintenance...
- Received up to or less than 2 lines of therapy prior to ASCT (as long as they did not meet IMWG refractory disease for CD38 monoclonal antibody or...
You likely can't join if
- Refractory to anti-CD38 monoclonal antibody therapy OR lenalidomide as defined by the IMWG (defined as non-responsive or progressive disease on...
- Prior intolerance to isatuximab or lenalidomide.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant requiring immunosuppressive therapy.
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include adequately treated basal cell or squamous cell...
- Known CNS involvement by multiple myeloma, defined by positive CSF cytology for plasma cells, leptomeningeal involvement, or parenchymal CNS...
See the full eligibility criteria
- NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive...
- Age \> 18 years
- Patients must have a confirmed diagnosis of multiple myeloma according to IMWG criteria. Patients with smoldering multiple myeloma, or plasma cell leukemia are not eligible. Patients must not have significant amyloid...
- R-ISS stage 1, 2 or 3 at diagnosis. If stage at diagnosis is not known, patient may be enrolled if the intent is to treat with post -ASCT maintenance therapy.
- Received up to or less than 2 lines of therapy prior to ASCT (as long as they did not meet IMWG refractory disease for CD38 monoclonal antibody or lenalidomide therapies as defined in exclusion).
- Patients are planned to undergo ASCT with high dose melphalan, or have completed ASCT with high dose melphalan within the last 180 days and have not yet initiated post-ASCT maintenance.
- Obtain at least partial response according to IMWG criteria prior to autologous stem cell transplant
- ECOG performance status of 0, 1, or 2 within 30 days prior to enrollment.
- Demonstrate adequate organ function as defined in the table below; all screening labs are to be obtained within 30 days prior enrollment. Hematologic White blood cell (WBC) ≥ 1500/mm3 Absolute Neutrophil Count (ANC) ≥...
- Standard of care lenalidomide will not be provided by the sponsor or study and therefore study people must have confirmed access to lenalidomide for use during the study at the time of enrollment.
- Must be able to take and swallow oral medication (capsules) whole. Patients may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study...
- Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 5 months for females, and...
- Patients must be willing to take appropriate DVT prophylaxis, either aspirin, low molecular weight heparin, direct oral anticoagulants, or warfarin while receiving lenalidomide.
- Refractory to anti-CD38 monoclonal antibody therapy OR lenalidomide as defined by the IMWG (defined as non-responsive or progressive disease on therapy or within 60 days of last treatment).
- Prior intolerance to isatuximab or lenalidomide.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant requiring immunosuppressive therapy.
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II...
- Known CNS involvement by multiple myeloma, defined by positive CSF cytology for plasma cells, leptomeningeal involvement, or parenchymal CNS plasmacytoma at time of enrollment. Lumbar puncture is not required.
- Treatment with any investigational drug within 30 days prior to enrollment.
- Planned transplant is considered part of tandem autologous transplant approach for newly diagnosed MM.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or coronary angioplasty, unstable cardiac arrhythmia (ongoing...
- Pregnant women are excluded from this study because lenalidomide is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing...
- Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) may be enrolled if the viral load by polymerase chain reaction (PCR) is...
- Patients with a positive test for hepatitis B virus surface antigen (HBsAg) and/or HBV DNA indicating uncontrolled or active HBV infection. Patients with negative HBsAg and positive HBV viral load can be evaluated by a...
- Patients with known hepatitis C virus (HCV) viral load indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment. If a patient was started on...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Salt Lake City, Utah, 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 Chicago, Illinois, United States; Salt Lake City, Utah, 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.