Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma.

Last updated: April 12, 2024
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Platelet Disorders

Leukemia

Treatment

Ixazomib DX/Lenalidomide DX

Clinical Study ID

NCT05477797
KY2022-029-B
  • Ages 18-85
  • All Genders

Study Summary

Newly Diagnosed Myeloma Patients, who achieved efficacy above VGPR (very good PR)after initial treatment were enrolled. Patients were then randomly assigned to Id and Rd groups for maintenance treatment. Therapeutic effectiveness will be reviewed monthly until intolerant side effect or disease progression appear . The follow-up period is approximately 2 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult male or female patients aged 18 years or older with a confirmed diagnosis ofsymptomatic diagnosed multiple myeloma. Patients who have previously received initialtreatment (induction, transplantation and consolidation are considered to be the sameas first-line treatment) and the efficacy assessment ≥VGPR after the initial therapy.
  2. An informed consent form (ICF) has been signed. Considering the patient's condition,if the patient's signature is not conducive to the treatment of the disease, the legalguardian or the patient's immediate family will sign the informed consent;
  3. Female patients of child-bearing potential should meet both of the following criteria:
  4. Take effective contraceptive measures during the study and for three monthsfollowing the last dose;
  5. A negative serum pregnancy test at screening. Note: Women of childbearingpotential include all the female who have started menstruating and are notpost-menopausal and have not undergone surgical sterilization(eg, hysterectomy,double tubal ligation, bilateral oophorectomy). Postmenopause is defined asamenorrhea for more than 12 consecutive months due to unspecified reasons.
  6. Male subjects(including those undergo vasectomy) agree to use condoms if sexuallyactive with a female of child-bearing potential from the date of signing the informedconsent. And no plan of pregnancy throughout the study and for three months followingthe last dose.
  7. There are follow-up conditions. The patients known about the characteristics of thedisease and voluntarily join the study program for treatment and follow-up.
  8. Complete documentation of of the initial therapy is available.
  • Details of the state treatment and remission
  • cytogenetics at diagnosis
  • R-ISS staging at diagnosis
  1. Eastern Cooperative Oncology Group Performance Status of 0 to 2.
  2. Patient is willing and able to adhere to the study visit schedule and other protocolrequirements including blood sampling and bone marrow aspiration.
  3. Patients must meet the following clinical laboratory criteria at study entry:
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3 without growth factor support.Platelet count ≥ 75,000/mm3. Platelet transfusions to help patients meeteligibility criteria are not allowed within 3 days before randomization.
  • Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).
  • Alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN.
  • Calculated creatinine clearance ≥ 30 mL/min (using the Cockcroft-Gault equation.

Exclusion

Exclusion Criteria:

  1. Multiple myeloma that has relapsed after initial therapy.
  2. Radiotherapy or major surgery within 14 days before randomization.
  3. Diagnosed or treated for another malignancy within 1 years before randomization orprevious diagnosis with another malignancy with evidence of residual disease. Patientswith nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if theyhave undergone complete resection.
  4. Infection requiring IV antibiotic therapy or other serious infection within 14 daysbefore randomization.
  5. Evidence of current uncontrolled cardiovascular conditions, including uncontrolledhypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure,unstable angina.
  6. Systemic treatment with strong CYP3A inducers(rifampin, rifapentine, rifabutin,carbamazepine, phenytoin, phenobarbital) .
  7. Ongoing or active infection, known human immunodeficiency virus positive, activehepatitis B or C infection.
  8. Comorbid systemic illnesses or other severe concurrent disease that, in the judgmentof the investigator, would make the patient inappropriate for entry into this study orinterfere significantly with the proper assessment of safety and toxicity of theprescribed regimens (e.g., PN of any cause that is Grade 1 with pain or Grade 2 orhigher).
  9. Psychiatric illness/social situation that would limit compliance with studyrequirements.
  10. Known allergy to any of the study medications, their analogues, or excipients in thevarious formulations of any agent.
  11. Inability to swallow oral medication, inability or unwillingness to comply with thedrug administration requirements, or GI procedure that could interfere with the oralabsorption or tolerance of treatment.
  12. Treatment with any investigational products within 30 days before randomization.
  13. Female patient who is lactating and breastfeeding or has a positive serum pregnancytest during the Screening period.

Study Design

Total Participants: 420
Treatment Group(s): 1
Primary Treatment: Ixazomib DX/Lenalidomide DX
Phase:
Study Start date:
February 16, 2023
Estimated Completion Date:
January 15, 2026

Study Description

Newly Diagnosed Myeloma Patients, who achieved efficacy above VGPR after initial treatment were enrolled. Patients were then randomly assigned to Id and Rd groups for maintenance treatment. Therapeutic effectiveness will be reviewed monthly until intolerant side effect or disease progression appear . The follow-up period is approximately 2 years. Progression-free survival (PFS)was defined as the duration from randomization to the first evidence of disease progression or death from any cause. Overall survival (OS) was defined as the duration from the randomization to death from any cause. The Kaplan-Meier method was employed to plot the survival curves, with the log-rank test to assess the differences.

Connect with a study center

  • shanghai Jiaotong University School of Medicine, Renji Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

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