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

NCT05477797 | Recruiting DMC

• 1 other identifier: KY2022-029-B
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Progression Free Survival; Overall Survival; Maintenance

Keywords

multiple myeloma;; maintenance

Outcome Measures

Primary Outcomes (1)

• the percentage of 2 year PFS(progression-free survival)

  the percentage of the patients whose disease do not appear progression at the end of 2years maintenance from each group.

  from randomization to the end of 2years maintenance.

Secondary Outcomes (1)

• OS(overall survival)

  from duration from the randomization to the end of 2years maintenance

Other Outcomes (1)

• side effect

  from randomization to the end of 2years maintenance

Study Arms (2)

Ixazomib DX

EXPERIMENTAL

Id: Ixazomib 4mg po d1,8,15; Dexamethasone 20mg po d1,8,15,22; （28 days /cycle）. The treatment will be maintained for 2 years （if no disease progression or intolerant side effects appear）.

Drug: Ixazomib DX/Lenalidomide DX

Lenalidomide DX

PLACEBO COMPARATOR

Rd: Lenalidomide 25mg qd d1-21; Dexamethasone 20mg po d1,8,15,22; （28 days /cycle）. The treatment will be maintained for 2 years （if no disease progression or intolerant side effects appear）.

Drug: Ixazomib DX/Lenalidomide DX

Interventions

Ixazomib DX/Lenalidomide DX DRUG

After assessment of risk stratification，patients will be assigned to Id or Rd group randomly for maintenance therapy. Then they will be reviewed the efficacy monthly.

Also known as: Id/Rd

Ixazomib DX; Lenalidomide DX

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female patients aged 18 years or older with a confirmed diagnosis of symptomatic diagnosed multiple myeloma. Patients who have previously received initial treatment (induction, transplantation and consolidation are considered to be the same as first-line treatment) and the efficacy assessment ≥VGPR after the initial therapy.
• 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 legal guardian or the patient's immediate family will sign the informed consent;
• Female patients of child-bearing potential should meet both of the following criteria:
• Take effective contraceptive measures during the study and for three months following the last dose;
• A negative serum pregnancy test at screening. Note: Women of childbearing potential include all the female who have started menstruating and are not post-menopausal and have not undergone surgical sterilization(eg, hysterectomy, double tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for more than 12 consecutive months due to unspecified reasons.
• Male subjects(including those undergo vasectomy) agree to use condoms if sexually active with a female of child-bearing potential from the date of signing the informed consent. And no plan of pregnancy throughout the study and for three months following the last dose.
• There are follow-up conditions. The patients known about the characteristics of the disease and voluntarily join the study program for treatment and follow-up.
• Complete documentation of of the initial therapy is available.
• Details of the state treatment and remission
• cytogenetics at diagnosis
• R-ISS staging at diagnosis
• Eastern Cooperative Oncology Group Performance Status of 0 to 2.
• Patient is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
• 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 meet eligibility criteria are not allowed within 3 days before randomization.

You may not qualify if:

• Multiple myeloma that has relapsed after initial therapy.
• Radiotherapy or major surgery within 14 days before randomization.
• Diagnosed or treated for another malignancy within 1 years before randomization or previous diagnosis with another malignancy with evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Infection requiring IV antibiotic therapy or other serious infection within 14 days before randomization.
• Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina.
• Systemic treatment with strong CYP3A inducers(rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) .
• Ongoing or active infection, known human immunodeficiency virus positive, active hepatitis B or C infection.
• Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (e.g., PN of any cause that is Grade 1 with pain or Grade 2 or higher).
• Psychiatric illness/social situation that would limit compliance with study requirements.
• Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
• Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or GI procedure that could interfere with the oral absorption or tolerance of treatment.
• Treatment with any investigational products within 30 days before randomization.
• Female patient who is lactating and breastfeeding or has a positive serum pregnancy test during the Screening period.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Lu Zhong

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Liu

CONTACT

+86-18918186325; liujia1798@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were randomly divided into two groups（Id，Rd）after risk stratification.

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 28, 2022
• Study Start: February 16, 2023
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)