Consolidation therapy for newly diagnosed multiple myeloma after transplant

A Randomized, Multicenter Study Comparing Post-Transplant KPD Regimen Consolidation With No Consolidation in Newly Diagnosed Multiple Myeloma (NDMM) Transplant-eligible Patients

This study is testing if a combination treatment after a stem cell transplant can help people with newly diagnosed multiple myeloma have better outcomes and stay in remission longer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06879379 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a consolidation therapy regimen using carfilzomib, pomalidomide, and dexamethasone (KPD) following autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma. The primary objective is to compare the rates of minimal residual disease (MRD) negativity and overall treatment outcomes between those receiving KPD consolidation and those receiving no consolidation therapy. By clarifying the role of consolidation therapy, the study aims to enhance remission depth and prolong progression-free survival in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed multiple myeloma who are eligible for transplantation and have undergone autologous stem cell transplantation.

Not a fit: Patients who are not newly diagnosed or those who are not eligible for transplantation will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes and longer remission periods for patients with newly diagnosed multiple myeloma.

How similar studies have performed: Previous studies have shown promising results with consolidation therapies in multiple myeloma, suggesting that this approach may provide additional benefits.

Eligibility criteria

Inclusion 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:

  1. Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);
  2. Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;
  3. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;
  4. 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 contraceptive measures for at least 1 year thereafter. Male participants with fertile partners must agree to use effective barrier contraception during the period of using the study drug and within 3 months after the last administration of the study drug;
* The participant is willing and able to comply with the study procedures and voluntarily signs the written informed consent form.

Exclusion Criteria:

* 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 any autoimmune diseases involving the CNS;
* 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 any type of non-melanoma skin cancer or completely resected carcinoma in situ);
* 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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Fuxing Hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jin Lu, M.D. — Peking University People's Hospital
• Study coordinator: Xuelin Dou, M.D.

Conditions Multiple Myeloma, Newly Diagnosed; consolidation