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New treatment option for Newly Diagnosed Multiple Myeloma
Official title Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients
ClinicalTrials.gov ID: NCT05665140
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, given as an once-daily, being studied as a potential treatment for newly diagnosed multiple myeloma.
Also referred to as Sarclisa®.
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
- Multiple myeloma (MM) is a malignant disease of the BM characterized by clonal expansion of plasma cells. Current guidelines recommend that newly diagnosed transplant-eligible patients with multiple myeloma (NDMMTE) shall undergo several cycles of induction, followed by one or two cycles high-dose melphalan followed by autologous stem cell transfusion (ASCT).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- newly diagnosed, untreated, symptomatic, documented myeloma (according to the revised Hypercalcaemia, renal dysfunction, anaemia and bone lesions...
- Presence of measurable disease: I. Serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours. II. Involved FLC (free light chain) level ≥ 10...
- R-ISS stage I33 (see appendix 2)
- Standard gene expression pattern of isolated plasma cell based on SKY92 GEP assay
- Must be ≥ 18 and ≤70 years at the time of signing the informed consent form.
You likely can't join if
- Direct Coombs test positive hemolytic anemia.
- Involvement of the central nervous system (CNS).
- History or presence of clinically relevant CNS pathology such as clinically relevant epilepsy, seizure, paresis, aphasia, stroke, subarachnoid...
- Subject with active or history of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome or clinically significant amyloidosis.
- Patients having nonsecretory MM.
- Systemic AL amyloidosis (with exception of AL amyloidosis of BM).
See the full eligibility criteria
Who can join
- newly diagnosed, untreated, symptomatic, documented myeloma (according to the revised Hypercalcaemia, renal dysfunction, anaemia and bone lesions (CRAB) criteria 2014, see Appendix 1) with clonal bone marrow (BM) plasma...
- Presence of measurable disease: I. Serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours. II. Involved FLC (free light chain) level ≥ 10 mg/dl, provided sFLC (free light chain) ratio is abnormal.
- R-ISS stage I33 (see appendix 2)
- Standard gene expression pattern of isolated plasma cell based on SKY92 GEP assay
- Must be ≥ 18 and ≤70 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements in the investigator's opinion.
- WHO (see Appendix 3) performance status 0-2 (WHO=2 is allowed only if caused by MM and not by co-morbid conditions).
- Ability to understand and willingness to sign written informed consent. Signed informed consent must be obtained before any study specific procedure.
- Suitable for high-dose melphalan and stem cell retransfusion.
- people must have adequate vascular access for leukapheresis .
- Male or Female Male participants: A male participant must agree to use contraception during the intervention period and for at least 5 months after the last dose of isatuximab treatment and refrain from donating sperm...
- Combined (including estrogen and progesterone) hormonal contraception related to ovulation suppression\ :
- oral
- In the vagina
- Transdermal \ Due to the increased risk of venous thromboembolism in people with multiple myeloma taking lenalidomide and dexamethasone, the use of combined oral contraceptive pills are not recommended and the method...
- Progesterone-only hormone contraception associated with inhibition of ovulation\ :
- oral
- Injectable
- Implantable
- Intrauterine device (IUD)
- Intrauterine Hormone-releasing System (IUS)
- Vasectomized partner (with confirmed surgical success)
- Sexual abstinence (when consistent with the subject's usual lifestyle) IV. Investigational medicial product (IMP) may interact with hormonal contraceptives and may reduce the how well it works of contraceptive methods...
What rules you out
- Direct Coombs test positive hemolytic anemia.
- Involvement of the central nervous system (CNS).
- History or presence of clinically relevant CNS pathology such as clinically relevant epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's...
- Subject with active or history of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome or clinically significant amyloidosis.
- Patients having nonsecretory MM.
- Systemic AL amyloidosis (with exception of AL amyloidosis of BM).
- Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression or benign diseases, such as nonmalignant thyroid diseases. (Note: patients may have received a...
- Patients with any of the following laboratory abnormalities: I. Absolute neutrophil count (ANC) \ 2.5 × upper limit of normal (ULN) (unless due to liver infiltration by myeloma cells), serum total bilirubin \> 1.5 × ULN...
- Echocardiogram (ECHO) with left ventricular ejection fraction \< 45%.
- An inadequate pulmonary function defined as oxygen saturation (Sa02) \< 92 % on room air
- Known to be HIV+ or to have hepatitis A, B, or C active infection. Uncontrolled or active hepatitis B virus (HBV) infection: Patients with positive HBsAg and/or HBV DNA Of note: Patient can be eligible if anti-HBc...
- people with prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years.
- people with severe polyneuropathy with accompanying pain
- Hypersensitivity or allergy against any of the study drugs.
- Contraindications against any of the study drugs as outlined in the Investigator brochure or equivalent.
- Prisoners or people who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Participation in another treatment clinical trial during this trial or within 4 weeks before entry into this trial. There may be exceptions at the discretion of the (coordinating) investigator.
- Active systemic infection and severe infections requiring treatment with a parenteral administration of antibiotics.
- Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Bielefeld, Germany
- Hamburg, Germany
- Lübeck, Germany
- Münster, Germany
- Würzburg, Germany
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Bielefeld, Germany; Hamburg, Germany; Lübeck, Germany; Münster, Germany; Würzburg, Germany. 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.