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Tests treatment safety and results for Multiple Myeloma
Official title Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT06140966
What this study is testing
What is Daratumumab?
Daratumumab is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as Darzalex.
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 will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma
- 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 to 70
You may be able to join if
- Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)"Double hit"Multiple Myeloma (≥2 adverse markers...
- Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.
- Aged 18 years to 70 years.
- Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).
- Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy.
You likely can't join if
- No evidence of high-risk disease.
- Primary diagnosis of Waldenstrom's disease/POEMS syndrome/light chain amyloidosis.
- Received therapy for multiple myeloma.
- Prior or concurrent invasive malignancies.
- Eastern Cooperative Oncology Group (ECOG) score \>2 before induction chemotherapy.
- Clinically significant allergies or intolerance to daratumumab,carfilzomib,lenalidomide, dexamethasone, cisPlatin, epirubicin...
See the full eligibility criteria
- Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)"Double hit"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation)...
- Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.
- Aged 18 years to 70 years.
- Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).
- Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy.
- No evidence of high-risk disease.
- Primary diagnosis of Waldenstrom's disease/POEMS syndrome/light chain amyloidosis.
- Received therapy for multiple myeloma.
- Prior or concurrent invasive malignancies.
- Eastern Cooperative Oncology Group (ECOG) score \>2 before induction chemotherapy.
- Clinically significant allergies or intolerance to daratumumab,carfilzomib,lenalidomide, dexamethasone, cisPlatin, epirubicin, cyclophosphamide,melphalan, and etoposide.
- Participants with contraindication to thromboprophylaxis.
- Any uncontrolled or severe cardiovascular or pulmonary disease.
- Platelet count \< 50,000/μL, absolute neutrophil count \<1000/μL, and haemoglobin \<60 g/L before induction chemotherapy.
- Calculated creatinine clearance \ 3 times upper limit of normal (ULN). Bilirubin \>2 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin \>2.0 times ULN).
- Known to be seropositive for history of HIV or known to have active hepatitis B or hepatitis C.
- Ejection fraction by echocardiogram (ECHO) ≥ 45%, pulmonary function studies \<50% of predicted on mechanical aspects (Forced Expiratory Volume 1 (FEV1), Forced Vital Capacity (FVC) and diffusion capacity (DLCO) \< 50%...
- Uncontrolled or severe cardiovascular or pulmonary disease, clinically significant cardiac disease, uncontrolled diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with...
- Known/underlying medical conditions that, in the investigator's opinion, would make the administration of the study drug hazardous.
- Participant is a woman who is pregnant, or breast feeding, or planning to become pregnant while enrolled in this trial or within at least 6 months after the last dose of trial treatment. Or, participant is a man who...
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before treatment protocol registration or is currently enrolled in an treatment...
- Major surgery within 2 weeks before treatment protocol registration or has not fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Kyphoplasty or...
- Known or suspected of not being able to comply with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
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 Wuhan, Hubei, China. 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.