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A controlled clinical study of Ishazomib combined with cyclophosphamide and dexamethasone (ICD) versus Ishazomib combined with dexamethasone (ID) in the treatment of elderly/ineligible stem cell transplantation patients with newly diagnosed multiple myeloma

A controlled clinical study of Ishazomib combined with cyclophosphamide and dexamethasone (ICD) versus Ishazomib combined with dexamethasone (ID) in the treatment of elderly/ineligible stem cell transplantation patients with newly diagnosed multiple myeloma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040679
Enrollment
Unknown
Registered
2020-12-08
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

multiple myeloma

Interventions

Experimental group: Isazomi+cyclophosphamide+ dexamethasone
Control group:Isazomi+dexamethasone

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Untreated primary diagnosis of multiple myeloma according to IMWG criteria; 2. According to the IMWG standard disease can be measured: there are evaluable blood and urine M protein indicators (serum M-protein >=1g/dL (>=10 g/L), if subjects are IgA, IgD, IgE or IgM multiple myeloma, >=0.5 g/dL;Or urine M-protein level >=200 mg/24 h;Or light chain multiple myeloma, no measured lesion in serum or urine, serum immunoglobulin free light chain (FLC) >=10 mg/dL and serum immunoglobulin Kappa /lambda FLC ratio abnormal);Or there may be measurable extramedullary mass; 3. Aged 65 years old or above, or vulnerable patients; 4. The informed consent has been signed; 5. During the whole study period, the patients can regularly go to the research institution for relevant testing, evaluation and management.

Exclusion criteria

Exclusion criteria: 1. Patients who are known to be allergic to any study drug, its analogues, or excipients of different formulations in any preparation; 2. Patients with acute myocardial infarction, acute heart failure, acute cerebral infarction or acute cerebral hemorrhage and other cardiovascular and cerebrovascular events occurred within the last half month; 3. Patients who received live attenuated vaccine within 4 weeks before drug administration were studied for the first time; 4. Patients who are participating in other clinical trials; 5. Inability to understand or follow the research plan.

Design outcomes

Primary

MeasureTime frame
The Overall Response Rate;

Countries

China

Contacts

Public ContactGong Yuping

Department of Hematology, West China Hospital, Sichuan University

gongyuping2020@aliyun.com+86 18980601257

Outcome results

None listed

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