Risk Stratification and MRD-driven Maintenance for MM After ASCT

NCT06697483 | Recruiting

• 1 other identifier: 2024PHB165-001-20240930
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation. This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.

Conditions

Multiple Myeloma

Keywords

R2-ISS stage; Minimal Residual Disease; Lenalidomide; Daratumumab

Outcome Measures

Primary Outcomes (1)

• MRD (Minimal Residual Disease) status at 12 months after maintenance

  Bone marrow minimal residual disease status at 12 months after maintenance

  12 months

Secondary Outcomes (4)

• CR+VGPR

  12 months

• Estimated 3 year-PFS

  3 years

• Estimated 3 year OS

  3 years

• TRAEs

  3 years

Study Arms (2)

Lenalidomide

OTHER

For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance

Drug: Lenalidomide

Daratumumab and Lenalidomide

OTHER

For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance

Drug: Daratumumab; Drug: Lenalidomide

Interventions

Daratumumab DRUG

Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.

Daratumumab and Lenalidomide

Lenalidomide DRUG

Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation. Patients will receive the single drug lenalidomide maintenance.

Daratumumab and Lenalidomide; Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
• Must have a partial response (PR) or better response before maintenance.
• Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
• This study allows for post-ASCT consolidation therapy.
• ANC ≥ 1.0 x 10\^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10\^9/L (if BMPC \< 50%) or PLT ≥ 50 x 10\^9/L (if BMPC ≥ 50%).
• No active infection.
• a).TBIL\<1.5 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT \<3 x ULN.; c. Creatinine clearance ≥ 45mL/min.

You may not qualify if:

• Must not refractory or non-tolerate to lenalidomide in Arm A.
• Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
• Must not have progressed on multiple myeloma (MM) therapy before screening
• Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
• Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
• History of stroke or serious thrombotic event within 12 months prior to screening.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (4)

Fuxing Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasm, Residual

Interventions

daratumumab; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yang Dr, M.D.

CONTACT

+86-10-88326542; pkuphliuyang@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal of Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)