Consolidation therapy for newly diagnosed multiple myeloma after transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: dxldw@163.com
• Phone: +86-010-8649-1513

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MRD‑guided BCMA CAR-T with optional GPRC5D/CD3 BiTE consolidation for transplant‑ineligible newly diagnosed multiple myeloma

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• High‑dose transplant with BCMA CAR‑T followed by GPRC5D/CD3 bispecific antibody maintenance for ultra‑high‑risk newly diagnosed multiple myeloma

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  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07106710

• Frontline T-cell engager plus daratumumab versus autologous stem cell transplant with MRD-guided intensification for newly diagnosed multiple myeloma

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• Elranatamab plus lenalidomide after D-VRd and transplant for transplant-eligible newly diagnosed multiple myeloma

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• Low-dose teclistamab for newly diagnosed multiple myeloma patients

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  Recruiting Phase 2 Hospital Universitario Dr. Jose E. Gonzalez · Monterrey, Nuevo León · NCT06758375

• Fewer-doses daratumumab added to VRd for newly diagnosed multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.