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RecruitingNCT06697483Updated Nov 25, 2024

Risk Stratification and MRD-driven Maintenance for MM After ASCT

An interventional study of Daratumumab and Lenalidomide in Multiple Myeloma, sponsored by Peking University People's Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • R2-ISS stage
  • Minimal Residual Disease
  • Lenalidomide
  • Daratumumab
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 100 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Must have a partial response (PR) or better response before maintenance.
  3. Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
  4. This study allows for post-ASCT consolidation therapy.
  5. 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%).
  6. No active infection.
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. Must not refractory or non-tolerate to lenalidomide in Arm A.
  2. Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
  3. Must not have progressed on multiple myeloma (MM) therapy before screening
  4. Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
  5. Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
  6. History of stroke or serious thrombotic event within 12 months prior to screening.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Lenalidomide

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

    Drug: Lenalidomide

  • Other
    Daratumumab and Lenalidomide

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

    Drug: Daratumumab · Drug: Lenalidomide

Interventions

  • DrugDaratumumab

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

  • DrugLenalidomide

    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.

06

What researchers measure

Primary outcomes

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

    Bone marrow minimal residual disease status at 12 months after maintenance

    Time frame: 12 months

Secondary outcomes

  1. CR+VGPR

    complete response plus very good partial response at 12 months from maintenance

    Time frame: 12 months

  2. Estimated 3 year-PFS

    Estimated 3 year progression free survival

    Time frame: 3 years

  3. Estimated 3 year OS

    Estimated 3 year overall survival

    Time frame: 3 years

  4. TRAEs

    Treatment related adverse events

    Time frame: 3 years

07

Study locations

4 of 4 sites recruiting
  • Fuxing Hospital
    Beijing, Beijing 100038, China
    Recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100044, China
    Recruiting
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
    Recruiting
  • The First Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150001, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06697483
Lead sponsor
Peking University People's Hospital
Responsible party
Jin Lu, MD (Principal of Investigator, Peking University People's Hospital) — Principal investigator
First posted
Nov 20, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 25, 2024

Study contacts

Yang Dr, M.D.
Contact
pkuphliuyang@bjmu.edu.cn
+86-10-88326542

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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