A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma

Last updated: July 11, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT06497738
DRd
  • Ages > 65
  • All Genders

Study Summary

The purpose of the study is to compare the efficacy and safety of daratumumab, lenalidomide and dexamethasone (DRd) to that of modified bortezomib, lenalidomide and dexamethasone (VRd-lite), in terms of progression-free survival and minimal residual disease negativity rate in elderly participants with newly diagnosed multiple myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 65 years old

  2. Newly diagnosed Multiple myeloma patients with measurable disease. Diagnosis ofmultiple myeloma as documented per International Myeloma Working Group (IMWG)criteria:Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10percentage (%) or presence of a biopsy proven plasmacytoma and documented multiplemyeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteriaor SLiM. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upperlimit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinineclearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below thelower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolyticlesions on skeletal radiography, computed tomography (CT), or positron emissiontomography (PET)-CT. SLiM: Clonal bone marrow plasma cell percentage >=60%;Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion onmagnetic resonance imaging (MRI) studies. Measurable disease: Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200milligram[mg]/24 hours[hrs]); OR IgA, IgM, IgD, or IgE multiple myeloma (serumM-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR Lightchain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL andabnormal serum immunoglobulin kappa lambda free light chain ratio)

  3. Expected survival more than 3 months

  4. No active infectious disease

  5. Be able to understand the characteristics of the disease, voluntarily join thisstudy protocol for treatment and follow-up

  6. Have signed informed consent. Informed consent was obtained from the patientsthemselves or their immediate family members.

Exclusion

Exclusion Criteria:

  1. Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired,congenital immunodeficiency diseases.

  2. Peripheral neuropathy or neuropathic pain(except extramedullary disease compression)Grade 2 or higher, as defined by the National Cancer Institute Common TerminologyCriteria for Adverse Events (NCI-CTCAE) Version 5.

  3. Plasma cell leukemia, non-bone-related extramedullary lesions

  4. Severe thrombotic events before treatment

  5. The presence of grade 2 or higher peripheral neuropathy before treatment

  6. Liver dysfunction (alanine aminotransferase and aspartate aminotransferase ≥ 2.5times the upper limit of normal value)

  7. Total bilirubin ≥ 1.5 times the upper limit of normal value

  8. Major surgery within 30 days before enrollment

  9. Epilepsy, dementia and other mental abnormalities requiring drug treatment andcannot understand or follow the study protocol

  10. According to the protocol or the investigator's judgment, the patient has a seriousphysical or mental illness that may interfere with the participation in thisclinical study

  11. Drug abuse, medical, psychological or social conditions that may interfere with thesubject's participation in the study or the evaluation of the study results

  12. Patients who are receiving other experimental drug treatment

  13. Lactating or pregnant women

  14. The investigator believes that the participant is not suitable for enrollment

Study Design

Total Participants: 112
Study Start date:
May 01, 2024
Estimated Completion Date:
June 01, 2027

Study Description

This is a prospective, open-label, multicentered cohort study. This study will evaluate elderly participants with newly diagnosed multiple myeloma (MM) for whom hematopoietic stem cell transplant is not planned as initial therapy. All the eligible participants can be free to choose to receive either daratumumab lenalidomide and dexamethasone (DRd) or modified bortezomib lenalidomide and dexamethasone (VRd-lite). Daratumumab (16 milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (Cycle 7 to 8). Bortezomib will be administered subcutaneously 1.3 mg/m^2 weekly of each 28-day cycle for Cycles 1-8. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 20 mg twice a week for both treatment arms. Participants in both treatment arms will continue at least lenalidomide maintenance until disease progression or unacceptable toxicity.The primary endpoint will be progression-free survival (PFS) and percentage of participants with Negative Minimal Residual Disease (MRD). Participant safety will be assessed throughout the study.

Connect with a study center

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu 213000
    China

    Active - Recruiting

  • Nanjing First People's Hospital

    Nanjing, Jiangsu 21000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 226001
    China

    Active - Recruiting

  • Taizhou People's Hospital

    Taizhou, Jiangsu 225300
    China

    Active - Recruiting

  • Yancheng First People's Hospital

    Yancheng, Jiangsu 224006
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.