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New treatment option for Newly Diagnosed
Official title Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
ClinicalTrials.gov ID: NCT06409702
What this study is testing
What is Carfilzomib?
Carfilzomib is an investigational medicine, being studied as a potential treatment for newly diagnosed.
Also referred to as Kyprolis.
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
- The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma.
- Phase 4: studies an already-approved treatment
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
- patients with newly diagnosed multiple myeloma（may receive up to one course of a bortezomib-containing regimen for the urgent relief of bone pain...
- age ≥ 18 years;
- have an evaluable lesion; serum M protein ≥ 10 g/L, or urinary light chain ≥ 200 mg/24h, or involved serum free light chain (FLC) ≥ 100 mg/L, and an...
- ECOG physical status score ≤ 2
- or have a high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and/or TP53 mutation...
You likely can't join if
- monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, primary light chain amyloidosis with organ involvement.
- diagnosed or treated for another malignancy prior to pre-registration ≤ 1 year or previously diagnosed with another malignancy with evidence of any...
- other co-morbidities that would interfere with the subject's ability to participate in the trial, e.g., uncontrolled infections, uncompensated...
- peripheral neuropathy ≥ grade 1-2 with pain on clinical examination within 30 days prior to pre-registration
- major surgery within 14 days prior to pre-registration
- evidence of current uncontrolled cardiovascular disease, including uncontrolled hypertension (hypertension defined as SBP ≥ 140 mmHg and/or DBP ≥ 90...
See the full eligibility criteria
- patients with newly diagnosed multiple myeloma（may receive up to one course of a bortezomib-containing regimen for the urgent relief of bone pain, renal insufficiency, and hypercalcemia）;
- age ≥ 18 years;
- have an evaluable lesion; serum M protein ≥ 10 g/L, or urinary light chain ≥ 200 mg/24h, or involved serum free light chain (FLC) ≥ 100 mg/L, and an extramedullary measurable tumor SPD: The diameter of cutaneous nodules...
- ECOG physical status score ≤ 2
- or have a high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and/or TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes...
- or R-ISS stage 3
- or combined plasma cell leukemia (defined as peripheral blood sorted clonal plasma cells ≥ 5%)
- bone marrow function: neutrophils ≥ 1.0 x 109 /L, platelets ≥ 70 x 109 /L (if bone marrow plasma cells ≥ 50%, platelets ≥ 50 x 109 /L)
- AST, ALT, ALP ≤ 3 × upper limit of normal value, serum bilirubin ≤ 2 times upper limit of normal value;
- serum creatinine clearance ≥ 40mL/min
- negative pregnancy test for women of childbearing age; patients and their spouses must agree to use effective contraception during the treatment period and the following one-year period;
- Signed informed consent for chemotherapy. A legal representative will sign the informed consent form if the subject is unable to sign it due to impaired consciousness, paralysis of the subject's upper limbs, or...
- monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, primary light chain amyloidosis with organ involvement.
- diagnosed or treated for another malignancy prior to pre-registration ≤ 1 year or previously diagnosed with another malignancy with evidence of any residual disease being treated.
- other co-morbidities that would interfere with the subject's ability to participate in the trial, e.g., uncontrolled infections, uncompensated cardiac or pulmonary disease, other synchronized chemotherapy or any...
- peripheral neuropathy ≥ grade 1-2 with pain on clinical examination within 30 days prior to pre-registration
- major surgery within 14 days prior to pre-registration
- evidence of current uncontrolled cardiovascular disease, including uncontrolled hypertension (hypertension defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg on 3 non-same day office measurements without antihypertensive...
- Participants with known chronic obstructive pulmonary disease (COPD) (defined as exertional expiratory volume in 1 second [FEV1] \<50% of predicted normal volume), persistent asthma, or a history of asthma within the...
- moderate/severe renal insufficiency: creatinine clearance \< 40mL/min.
- known human immunodeficiency virus (HIV) positivity.
- Hepatitis B seropositivity (defined as a positive Hepatitis B surface antigen [HBsAg] test). people whose infection has resolved (i.e., people who are HBsAg negative but positive for Hepatitis B Core Antigen Antibody...
- known or suspected active hepatitis C infection.
- any medical or psychiatric condition that, in the opinion of the investigator, may interfere with the completion of treatment under this protocol.
- known allergy or intolerance to the test drug.
- inability to comply with the protocol/procedure.
- people will be ineligible to participate in the trial because the genotoxic, mutagenic, and teratogenic effects of the investigational drug(s) involved in this trial on the developing fetus and neonate are unknown if...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Compensation & support
A stipend or compensation may be offered.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, 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.