BridgeMD
New treatment option for Multiple Myeloma, Newly Diagnosed
Official title KPD Consolidation After ASCT in NDMM Patients
ClinicalTrials.gov ID: NCT06879379
What this study is testing
What is KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation?
KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation 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 aims to evaluate the efficacy and safety of post-transplant consolidation therapy with the KPD regimen (carfilzomib, pomalidomide, and dexamethasone) versus no consolidation, followed by maintenance therapy, in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM). The primary goal is to compare minimal residual disease (MRD) negativity rates and overall treatment outcomes between the two groups.
- 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 and older
You may be able to join if
- Age ≥18 years.
- Newly diagnosed MM eligible for transplantation.
- Received upfront triplet or quadraplet induction regimen.
- Received upfront ASCT after induction.
- ECOG score \< 2.
You likely can't join if
- Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
- Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering...
- Patients with severe mental disorders, altered mental status, or a history of central nervous system (CNS) diseases such as epileptic seizures...
- Patients with a history of the following genetic diseases: Fanconi anemia, Shwachman-Diamond syndrome, Costello syndrome, or any other known bone...
- Patients who underwent a diagnosis or treatment for another malignancy within 1 year prior to randomization, or had a previous diagnosis of another...
- Patients with active infectious diseases, known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection;
See the full eligibility criteria
- Age ≥18 years.
- Newly diagnosed MM eligible for transplantation.
- Received upfront triplet or quadraplet induction regimen.
- Received upfront ASCT after induction.
- ECOG score \< 2.
- Adequate Organ Function Reserve:
- Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);
- Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;
- Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;
- Basal oxygen saturation \> 95% in room air;
- Women of childbearing age agree to use effective contraceptive measures during the period of using the study drug and within 3 months after the last administration of the study drug; and to use highly effective...
- The participant is willing and able to comply with the study procedures and voluntarily signs the written informed consent form.
- Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
- Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
- Patients with severe mental disorders, altered mental status, or a history of central nervous system (CNS) diseases such as epileptic seizures, cerebral vascular ischemia/ hemorrhage, dementia, cerebellar diseases, or...
- Patients with a history of the following genetic diseases: Fanconi anemia, Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrow failure syndrome;
- Patients who underwent a diagnosis or treatment for another malignancy within 1 year prior to randomization, or had a previous diagnosis of another malignancy with evidence of residual disease (excluding patients with...
- Patients with active infectious diseases, known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection;
- Patients known to be allergic to any of the study drugs, their analogs, or any excipients of the study drugs in various formulations;
- Patients with concurrent or suspected central nervous system infiltration;
- Patients with drug use, medical, psychological, or social conditions that may interfere with the participant's ability to participate in the study or the assessment of study outcomes;
- Pregnant or lactating women;
- Any other conditions deemed by the investigator as unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, 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.