Pomalidomide maintenance therapy for primary multiple myeloma

Clinical Research of Pomalidomide Maintenance Therapy for Primary Multiple Myeloma

This study is testing if a daily dose of Pomalidomide can help people with primary Multiple Myeloma live longer without their disease getting worse after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: LanZhou University (Academic / other)
• Locations: 1 site (Lanzhou, Gansu)
• Trial ID: NCT05378971 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of maintenance therapy using Pomalidomide in patients with primary Multiple Myeloma (MM). It is a single-center, single-arm study enrolling 15 patients, divided into those suitable for Autologous Hematopoietic Stem Cell Transplantation (ASCT) and those not suitable. Patients will receive Pomalidomide at a dose of 2 mg daily for 28 days in cycles over a total duration of 36 months or until disease progression occurs. The primary endpoint is 2-year progression-free survival, with secondary endpoints including overall survival and remission rates.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with symptomatic primary multiple myeloma, either suitable for ASCT or those who have achieved maximum efficacy after induction therapy.

Not a fit: Patients with non-symptomatic multiple myeloma or those who have progressed after ASCT may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could improve progression-free survival and overall outcomes for patients with primary multiple myeloma.

How similar studies have performed: Previous studies have shown promising results with similar maintenance therapies using Pomalidomide, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject diagnosed as initially diagnosed with symptomatic MM by the diagnostic criteria of International Myeloma Working Group(IMWG), aged ≥ 18 years.
2. Subject undergoing ASCT who have had prior induction therapy for no more than 12 months and whose disease has not progressed within 3 months of ASCT.
3. Subject who are not candidates for ASCT have reached maximum efficacy after induction and consolidation therapy.
4. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-3.
5. Serum transaminase levels less than three times the upper limit of normal, serum total bilirubin levels not exceeding 35 umol/L, serum creatinine levels less than 177 umol/L, absolute neutrophil values greater than 1.0 x 10\^9/L, and platelet counts greater than 75 x 10\^9/L.
6. Subject of childbearing potential must use two reliable methods of contraception simultaneously or have absolutely no sexual relations with the opposite sex for 4 weeks prior to initiation of treatment, during treatment, during suspension of dosing and for 4 weeks after termination of treatment, and women of childbearing potential agree to perform monthly pregnancy tests until 4 weeks after discontinuation of study drug.
7. Subject voluntarily enrolled in this study and signed an informed consent form.

Exclusion Criteria:

1. Subject has 17p-, 1q21 amplification, t(4;14), t(14;16), t(14;20), t(11;14), and p53 mutation.
2. Subject who, in the judgment of the investigator, cannot tolerate pomalidomide treatment or are allergic to lenalidomide or thalidomide drugs.
3. Subject with a diagnosis of nonsecretory MM (meaning subjects with completely nonsecretory MM or subjects with a small amount of free light chain but with less than 100 mg/L of affected light chain).
4. with central nervous system involvement.
5. subject with peripheral neuropathy ≥ grade 3.
6. subject with known active hepatitis B virus (HBV-DNA ≥ l × 103 copies/mL or HBV-DNA \> 200 IU/mL) or hepatitis C virus (HCV), or serologically positive for human immunodeficiency virus (HIV).
7. Subject with concurrent other neoplasms or a prior history of neoplasms or antineoplastic therapy (including major surgery) within the last 4 weeks, except for the following neoplastic diseases or those who have lived tumor-free for ≥ 3 years to date: basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic findings of prostate cancer (TNM clinical stage of T1a or T1b) or treated prostate cancer.
8. Subject with coexisting serious infectious disease.
9. Subject who refuse to use a reliable form of contraception during pregnancy and lactation or at an appropriate age.
10. Subject with active new thrombosis or unwilling to undergo antithrombotic therapy.
11. Subject who, in the opinion of the investigator, are not suitable for enrollment.

Where this trial is running

Lanzhou, Gansu

• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)

Study contacts

• Principal investigator: Hao Zhang — The First Hospital of Lanzhou University,Lanzhou, Gansu, China
• Study coordinator: Hao Zhang

Conditions Multiple Myeloma; Multiple myeloma; Maintenance treatment; Pomalidomide