BridgeMD
Compares treatment options for Newly Diagnosed Multiple Myeloma
Official title NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide
ClinicalTrials.gov ID: NCT05558319
What this study is testing
What is Bortezomib?
Bortezomib is an investigational medicine, given as an once-weekly, being studied as a potential treatment for newly diagnosed 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 III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation.
- 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 65
You may be able to join if
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient must be able to understand the study procedures.
- Patient has given voluntary written informed consent before performance of any studyrelated procedure non part of normal medical care, with the...
- Newly diagnosed multiple myeloma patient who requires start active treatment according to the 2014 IMWG criteria, namely clonal bone marrow plasma...
- Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥...
You likely can't join if
- Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma...
- Patient has had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple...
- Prior history of malignancies, other than multiple myeloma (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix...
- Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study; people with conditions...
- Pregnant or breastfeeding females.
- Men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral...
See the full eligibility criteria
Who can join
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient must be able to understand the study procedures.
- Patient has given voluntary written informed consent before performance of any studyrelated procedure non part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time...
- Newly diagnosed multiple myeloma patient who requires start active treatment according to the 2014 IMWG criteria, namely clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any...
- Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients whose disease is only measurable by serum...
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Patient must be ≤ 65 years of age.
- Patient must have adequate organ function, defined as follows:
- Absolute neutrophil count (ANC) ≥1.0 X 109/L without G-CSF use in the prior 7 days
- Hemoglobin ≥8.0 g/dL (prior red blood cell (RBC) transfusion or recombinant human erythropoietin use is permitted)
- Platelets ≥ 75 x 109/L in participants in whom \<50% of bone marrow nucleated cells are plasma cells and ≥ 50×109/L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion...
- Calcium Corrected serum calcium ≤13.5 mg/dL (≤3.4 mmol/L); or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L).
- Total bilirubin ≤2 X ULN
- ALT ≤2.5 X ULN
- AST ≤2.5 X ULN
- Renal: eGFRa: ≥40 mL/min/ 1.73 m2
- Cardiac: LVEF (echo) ≥ 50%
- Female patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female patient is eligible to participate if she is not...
- Is not a woman of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral...
- Is a WOCBP and
- She understands the potential teratogenic risk to the unborn child
- She understands the need for effective contraception as stated in the protocol, without interruption, 28 days before starting study treatment, throughout the entire duration of study treatment, during dose interruptions...
- She understands and agrees to inform the Investigator if a change or stop of method of contraception is needed.
- She must be capable of complying with effective contraceptive measures.
- She is informed and understands the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy.
- She understands the need to commence study treatment as soon as it is dispensed following a negative pregnancy test.
- She understands and accepts the need to undergo pregnancy testing based on the frequency outlined in this plan and in the Informed Consent.
- She acknowledges she understands the hazards iberdomide or lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of study drugs. The Investigator must ensure that a WOCBP: i)...
- Has not achieved menarche at some point.
- Has undergone a hysterectomy or bilateral oophorectomy.
- Has been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
- Male patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male patient is eligible to participate if he agrees to the...
- Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a WOCBP.
- Understand the need for the use of a condom even if he has had a vasectomy, if engaged in sexual activity with a pregnant female or a FCBP
- Understand the potential teratogenic risk, so the subject should not donate semen or sperm.. Understand that the effects on fertility are currently unknown, therefore all family planning options and/or alternatives...
- All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 must be ≤ Grade 1 at the time of enrolment except for alopecia.
What rules you out
- Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia or active POEMS syndrome at the time of screening.
- Patient has had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma.
- Prior history of malignancies, other than multiple myeloma (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or the breast), unless the patient has been free of the disease for ≥...
- Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study; people with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid...
- Pregnant or breastfeeding females.
- Men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception).
- Patient is simultaneously enrolled in other treatment clinical trial.
- Patient has used an investigational drug within 28 days or five half-lives, whichever is longer, preceding the first dose of study drug.
- Patient must not have received prior radiotherapy (except localized palliative radiotherapy for pain, palliation or fracture) within 2 weeks of start of study therapy. Participants must have recovered from all...
- Major surgery (except kyphoplasty) ≤ 4 weeks prior to initiating protocol therapy.
- Patient has peripheral neuropathy or neuropathic pain grade 1 with pain or ≥2, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
- Patient evidence of cardiovascular risk including any of the following:
- Myocardial infarction within 6 months before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart...
- Uncontrolled cardiac arrhythmia.
- Screening 12-lead ECG showing a baseline interval QTcF\> 470 msec (exception: people with pacemaker).
- Patients with uncontrolled hypertension.
- Patients who have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note...
- Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they...
- Evidence of active mucosal or internal bleeding.
- Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form.
- Uncontrolled endocrine diseases (i.e. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).
- Patient with acute diffuse infiltrative pulmonary disease and/or pericardial disease.
- Patient with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEV1) less than 50%.
- History of interstitial lung disease or ongoing interstitial lung disease.
- Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and/or other oral study treatment.
- Patient has an active infection requiring systemic antibiotic, antiviral, or antifungal treatment at the time of starting treatment.
- Patient has known HIV infection.
- Patient has positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment.
- Patient has positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody...
- Patient require concurrent administration of a strong inhibitor or inducer of cytochrome P450 (CYP3A4/5) (including within 14 days of initiating study treatment).
- Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to iberdomide or drugs chemically related to iberdomide.
- Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to isatuximab or drugs chemically related to isatuximab, hypersensitivity reactions, or idiosyncratic reactions to other...
- Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to lenalidomide or dexamethasone or drugs chemically related to lenalidomide or dexamethasone.
The study team makes the final eligibility decision.
Where it's taking place
- Alcalá de Henares, Madrid, Spain
- Pozuelo de Alarcón, Madrid, Spain
- Pamplona, Navarre, Spain
- Albacete, Spain
- Badalona, Spain
- Barcelona, Spain
- Bilbao, Spain
- Burgos, Spain
- Cáceres, Spain
- Gijón, Spain
- Girona, Spain
- Granada, Spain
- Guadalajara, Spain
- Jerez de la Frontera, Spain
- León, Spain
- Lleida, Spain
- Logroño, Spain
- Lugo, Spain
- Madrid, Spain
- Málaga, Spain
+ 22 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alcalá de Henares, Madrid, Spain; Pozuelo de Alarcón, Madrid, Spain; Pamplona, Navarre, Spain; Albacete, Spain; Badalona, Spain; Barcelona, Spain and 36 more location(s). 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.