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A prospective exploratory study of maintenance therapy with pegylated interferon a-2b in patients with multiple myeloma whose MRD was positive after consolidation therapy

A prospective exploratory study of maintenance therapy with pegylated interferon a-2b in patients with multiple myeloma whose MRD was positive after consolidation therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048763
Enrollment
Unknown
Registered
2021-07-16
Start date
2021-07-19
Completion date
Unknown
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

therapy group A:The dose of PEG-IFN a-2b was 90 µ g, subcutaneously injected for 28 days, once a week, 1-2 times per course, and the researchers adjusted the times of administration according to the t
therapy group B:The dose of lenalidomide is 10mg / 25mg, orally, one course of treatment for 28 days, each course of treatment for 21 days
maintenance therapy lasts at least 6 courses, which can be judged by the researchers to increase the course of maintenance therapy.

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. MM newly diagnosed patients or patients who enter maintenance therapy after consolidation therapy (including chemotherapy or transplantation), MRD positive, and curative effect >= PR; 2. ISS staging is medium and high risk patients; 3. Aged 18 to 70 years old; 4. Never used interferon therapy before; 5.ECOG=1.0x10^9/L, PLT>=50x10^9/L; 7. Serum creatinine <2.0 mg/dL, serum bilirubin <=2 times the upper limit of normal; 8. Subjects signed informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to active ingredients, alpha-interferon or any excipients of this product; 2. Autoimmune chronic hepatitis; 3. Severe liver dysfunction or decompensated cirrhosis; 4. History of serious heart disease, including unstable or uncontrolled heart disease within 6 months; 5. Have severe mental illness or a history of serious mental illness, mainly depression; 6. Pregnant women or women planning to become pregnant and breastfeeding, or men with childbearing plans; 7. Severe kidney disease (on hemodialysis), epilepsy (needs antispasmodic treatment); 8. History of other malignant tumors within three years; 9. Systemic infection (such as HBV/HCV or HIV, etc.); 10. Those who are judged by the investigator to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The level of MRD decreased in patients.;

Countries

China

Contacts

Public ContactFang Baijun

Henan Cancer Hospital

718679894@qq.com+86 13027705507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026