A phase II trial of selinexor, pomadomide, bortezomib combined with dexamethasone in newly diagnosed multiple myeloma with renal insufficiency

Efficacy and safety of selinexor, pomadomide, bortezomib combined with dexamethasone in the treatment of newly diagnosed multiple myeloma with renal insufficiency: a prospective, single-arm, multicenter, phase II clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064695

Enrollment

Unknown

Registered

2022-10-14

Start date

2022-10-15

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Multiple myeloma

Interventions

Single-arm:Selinexor, pomadomide, bortezomib combined with dexamethasone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. According to IMWG 2014, newly diagnosed patients with multiple myeloma; 2. Aged from 18 to 75 years old; 3. Renal insufficiency at diagnosis, defined as EGFR 30% of total protein in urine, it must be confirmed by renal biopsy. 5. Expected survival time > 6 months; 6. MM with measurable lesions (blood M component >= 10g/L; Urine M >= 200mg/24h; Affected FLC >= 100mg/L); 7. There was no chronic renal insufficiency one year ago; 8. ECOG=50*10^9/L within 14 days before enrollment; 11. Absolute neutrophil count >=0.5*10^9/L within 14 days before enrollment; 12. < grade 2 peripheral neuropathy within 14 days enrollment; 13. No plasma exchange within 1 week before enrollment; 14. Those who agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Although there is cast nephropathy, it is a secondary lesion; Renal insufficiency caused by other causes is the main lesion, including but not limited to renal amyloidosis, light chain deposition disease, etc.; 2. The patient has a history of allergy to Selinexor or its components, pomadomide, or any excipient and/or bortezomib; 3. Within 6 months before enrollment, patients suffered from uncontrolled or severe cardiovascular diseases, including myocardial infarction, class II-IV heart failure defined by New York Heart Association (NYHA), uncontrolled angina pectoris, clinically significant pericardial diseases, or cardiac amyloidosis; 4. Female patients are in pregnancy or lactation; 5. Other malignant tumors, uncontrollable infections, serious physical diseases, or mental diseases may interfere with the participation in this clinical study; 6. Those who can't understand and follow the research plan or sign the informed consent form; 7. During the research, women and men of childbearing age agreed to take appropriate and effective contraceptive measures.

Design outcomes

Primary

Measure	Time frame
3-month overall renal remission rate;	—

Secondary

Measure	Time frame
Hematological remission rate;6-month and 12-month overall renal remission rate;Progression free survival;Overall survival;	—

Countries

China

Contacts

Public ContactWen Gao

Beijing Chaoyang Hospital, Capital Medical University

gaowenpingping@163.com+86 010-85231572

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026