Clinical trial for Relapsed Cancer
Official title Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05922501
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for relapsed cancer.
Also referred to as SAR650984.
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 study aims to find out how many people's cancer shrinks or goes away when treated with this specific combination of drugs.
- Who it's for
- The study is looking for adults with multiple myeloma that has returned or is no longer responding to previous treatments.
- What's involved
- Participants will receive isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone, along with regular medical checks and tests to monitor their health.
- Time commitment
- The source text does not specify the total duration of the study or the exact schedule of required visits.
- 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
- Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
- Age ≥ 18 years
- Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
- ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
You likely can't join if
- Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.
- Participant must not use contact lenses while participating in this study.
- Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from...
- Participants who are receiving any investigational agents.
- Prior therapy with anti-CD38 monoclonal antibody within six months.
- Prior therapy with anti-BCMA therapy.
See the full eligibility criteria
Who can join
- Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
- Age ≥ 18 years
- Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
- ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Involved serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free light chain ratio
- Patients must have received at least one prior line of therapy;
- Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen); and
- Disease progression on or within 60 days of completion of last therapy.
- ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening. Patients with ANC \<1000/µL can be considered for screening on a case-by-case basis with additional monitoring, after discussion with and approval from...
- Platelet count ≥ 75,000/µL. Platelet transfusion is not permitted within 7 days of screening.
- Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.
- Calculated creatinine clearance of ≥ 30 mL/min by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula
- Spot urine (albumin/creatinine ratios (spot urine) \< 500 mg/g or urine dipstick negative/trace.
- Serum bilirubin values \< 1.5 × ULN. Isolated bilirubin ≥ 1.5 × ULN is acceptable if bilirubin is fractionated and direction bilirubin \<35%.
- Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values \< 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range.
- Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin, apixaban, rivaroxaban, or equivalent.
- All study participants must be registered into the mandatory Pomalyst REMS program and be willing and able to comply with the requirements of the Pomalyst REMS program.
- ≥ 45 years of age and has not had menses for \> 1 year
- Patients who have been amenorrhoeic for \< 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound.
- A man who is sexually active with a WOCBP (even if they have undergone a successful vasectomy) must agree to use a barrier method of birth control e.g.
- Male participants must refrain from donating sperm for 6 months after the last dose of study drug.
- Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).
What rules you out
- Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.
- Participant must not use contact lenses while participating in this study.
- Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- Participants who are receiving any investigational agents.
- Prior therapy with anti-CD38 monoclonal antibody within six months. No other multiple myeloma monoclonal antibody therapy within 30 days of start of study treatment.
- Prior therapy with anti-BCMA therapy.
- Plasmapheresis within seven days prior to start of study treatment.
- Primary refractory disease.
- Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose prednisone 10 mg/day or equivalent) are permitted if given for disorders other than myeloma, e.g.
- Pregnancy or lactation or planned lactation (breastfeeding).
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Ductal carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance
- Patients with active plasma cell leukemia at time of screening, POEMS syndrome, or primary AL amyloidosis are excluded from this trial.
- Seropositive for HIV infection
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]; see exception below).
- Seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy).
- Peripheral neuropathy ≥ grade 2 despite supportive therapy.
- Hypersensitivity to isatuximab, belantamab mafodotin, pomalidomide, or dexamethasone, such as Stevens-Johnson syndrome. Rash to immunomodulatory drug that can be medically managed is allowed.
- Allogeneic stem cell transplant \<12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are...
- Autologous stem cell transplant \<6 months prior to start of treatment
- Congestive heart failure (New York Heart Association [NYHA] Class 3 or 4)
- Unstable angina
- Clinically significant, uncontrolled cardiac arrhythmia such a 2nd degree or 3rd degree atrioventricular block
- Recent (within the preceding 6 months) myocardial infarction or stroke
- Uncontrolled hypertension
- Diabetes mellitus with \> 2 episodes of ketoacidosis in the preceding 12 months
- Chronic obstructive pulmonary disease (COPD) requiring \> 2 hospitalizations in the preceding 12 months.
- Unstable liver or biliary disease
- Active bacterial, viral, or fungal infection
- Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of...
- Major surgery within 4 weeks prior to C1D1.
- Live or live-attenuated vaccine within 30 days prior to C1D1.
- Toxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1, except for alopecia and peripheral neuropathy.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.