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Compares treatment options for Multiple Myeloma, Newly Diagnosed
Official title Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
ClinicalTrials.gov ID: NCT06918002
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, being studied as a potential treatment for multiple myeloma, newly diagnosed.
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 is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT. 824 patients will be enrolled in this study from approximately 70 study sites.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 69
You may be able to join if
- Male or female people, aged over 18 but \< 70 years old
- Patients have provided voluntary written informed consent before performing any study-related procedure.
- Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT).
- Patients with documented symptomatic NDMM according to CRAB and/or SLIM criteria, with measurable disease as defined by:
- Presence of ≥10% monoclonal plasma cells in the bone marrow OR presence of a biopsy-proven plasmacytoma. In addition, the patient must have ≥1 of the...
You likely can't join if
- people previously treated with any systemic therapy for multiple myeloma. Patients are allowed corticosteroids before or during screening, as far as...
- Subject with ongoing Grade ≥ 3 peripheral sensory or motor neuropathy.
- Subject with history of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
- Subject with a current diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or solitary...
- Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma...
- The subject has had plasmapheresis within 14 days of initiating induction therapy.
See the full eligibility criteria
Who can join
- Male or female people, aged over 18 but \< 70 years old
- Patients have provided voluntary written informed consent before performing any study-related procedure.
- Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT).
- Patients with documented symptomatic NDMM according to CRAB and/or SLIM criteria, with measurable disease as defined by:
- Presence of ≥10% monoclonal plasma cells in the bone marrow OR presence of a biopsy-proven plasmacytoma. In addition, the patient must have ≥1 of the following myeloma defining events: \- Hypercalcemia: serum calcium...
- More than 1 focal lesion (≥5 mm diameter) on MRI.
- Measurable disease as defined by serum M-component ≥5 g/L, and/or urine M-component ≥200 mg/24 h and/or serum FLC ≥100 mg/L.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
- Patients must have clinical laboratory values (within 15 days of initiating induction therapy) as follows:
- Hemoglobin ≥7.5 g/dL (≥5 mmol/L). Prior red blood cell (RBC) transfusion or the use of recombinant human erythropoietin is permitted.
- Absolute neutrophil count (ANC) ≥1.0 G/L (granulocyte colony stimulating factor [G-CSF] use is permitted).
- Aspartate aminotransferase (AST) ≤3 x ULN.
- Alanine aminotransferase (ALT) ≤ 3 x ULN.
- Total bilirubin ≤3 x ULN (except in people with congenital bilirubinemia, such as Gilbert syndrome, that require a direct bilirubin ≤3 x ULN).
- Calculated creatinine clearance ≥40 mL/min/1.73 m².
- Albumin corrected serum calcium ≤14 mg/dL (\<3.5 mmol/L); or free-ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L).
- Platelet count ≥50 Giga/L for people who have \ 30 G/L (platelets transfusions done during the 15 days before initiating induction therapy are not permitted).
- Women of childbearing potential must have a negative serum or urine pregnancy test during the screening period before randomization AND within 3 days before of initiating induction therapy.
- Patients must be willing and able to comply with scheduled appointments, treatment plan, laboratory tests, and other study procedures (such as blood transfusion if required, ASCT, IVIG prophylaxis, etc.).
What rules you out
- people previously treated with any systemic therapy for multiple myeloma. Patients are allowed corticosteroids before or during screening, as far as the total dose received is not \>160 mg of dexamethasone (or...
- Subject with ongoing Grade ≥ 3 peripheral sensory or motor neuropathy.
- Subject with history of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
- Subject with a current diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or solitary plasmacytoma.
- Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- The subject has had plasmapheresis within 14 days of initiating induction therapy.
- Subject with clinical signs of meningeal involvement of multiple myeloma.
- The subject has plasma cell leukemia (by WHO criterion: ≥5% of plasma cells in the peripheral blood) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Subject has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study...
- Subject has clinically significant cardiac disease, including:
- Subject has had myocardial infarction within 1 year before initiating induction therapy, or currently has an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina...
- Subject has uncontrolled cardiac arrhythmia (common terminology criteria for adverse events [CTCAE] version 4 grade ≥2) or clinically significant electrocardiography (ECG) abnormalities.
- Subject with a baseline QT interval as corrected by Fridericia's formula (QTcF) \>470 msec (12-lead ECG).
- people taking systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole)...
- Known intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study...
- Known allergies to any of the study medications, their analogues, or excipients in the various formulations.
- people who have had major surgery within 2 weeks before study inclusion (signing of the informed consent) OR will not have fully recovered from surgery before initiating induction therapy OR have surgery planned during...
- people with any prior or concurrent malignancy (other than multiple myeloma) within 5 years of study inclusion study, except for adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of...
- Pregnant or breast-feeding women. Women that refuse to abstain from heterosexual intercourse or refuse to use adequate contraceptives during heterosexual intercourse starting at least 4 weeks before initiating induction...
- Active HCV infection: positive HCV RNA and negative anti-HCV. Of note: Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Annecy, France
- Argenteuil, France
- Avignon, France
- Bayonne, France
- Besançon, France
- Blois, France
- Bobigny, France
- Bordeaux, France
- Bourg-en-Bresse, France
- Brest, France
- Caen, France
- Chalon-sur-Saône, France
- Chambéry, France
- Chartres, France
- Clamart, France
- Clermont-Ferrand, France
- Corbeil-Essonnes, France
- Créteil, France
+ 39 more site(s).
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 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Annecy, France; Argenteuil, France; Avignon, France; Bayonne, France and 53 more location(s). 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.