Study of Pomalidomide, Oral Dexamethasone and Ixazomib in Patients With Relapsed MM Who Have Received Lenalidomide

NCT04989140 | Unknown Phase 4 FDA Drug

• 1 other identifier: HS-2883
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ixazomib, oral dexamethasone and in patients with relapsed multiple myeloma who have received lenalidomide.

Conditions

Multiple Myeloma

Keywords

relapsed MM; oral regiment

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  From enrollment to first disease progression

  Time Frame: From date of enrollment until the date of first documented progression, assessed up to 24 months

Secondary Outcomes (4)

• Adverse events assessment

  Each cycle, up to 24 months of follow-up.

• Overall survival

  At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up

• Overall response rate

  At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up

• Time to next treatment

  At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up

Study Arms (1)

IxaPD

EXPERIMENTAL

Ixazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of every 28-day cycle , pomalidomide 25mg qd day 1\~21 of every 28-day cycle, Dexamethasone 40 mg (20 mg for patients \>75 years of age) was given on days 1, 8, 15, and 22 of every 28-day cycle.

Drug: Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone

Interventions

Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone DRUG

Treatment was continued until disease progression, unacceptable toxicity

IxaPD

Eligibility Criteria

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

You may qualify if:

• Male or female patients 18 years of age or older;
• Newly diagnosed MM patients who fulfill the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised in 2020) Standards;
• Patients with relapsed MM who have received 1 to 3 prior therapies (including lenalidomide);
• There must be a washout period of two weeks (14 days) from the last treatment (excluding dexamethasone treatment);
• Previously untreated subjects with ixazomib or pomalidomide;
• Subjects of childbearing age should take effective contraceptive measures and must agree to comply with all contraceptive requirements; Contraceptive requirements: women with fertility must decide to adopt two reliable contraceptive methods at the same time (a highly effective method of contraception-fallopian tube ligation, intrauterine contraceptive device, hormones (contraceptive pills, needles, patches, vaginal rings or implants) ) Or partner's vas deferens ligation, another effective contraceptive program-male rubber or synthetic condoms, diaphragm or cervical cap); unless the cause of hysterectomy, or a history of infertility in time, effective contraception is also required. Men must agree to use a latex condom during sexual contact with a Females of childbearing potential even if they have had a successful vasectomy;
• Patients must have measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein≥5 g/ L, Urine M-protein≥200 mg/24 hours, Serum free light chain assay: involved free light chain level≥100 mg/L, provided that the serum free light chain ratio is abnormal;
• Hematology satisfies the following conditions: when myeloma cells are less than 50%, ANC≥1.0×109/L (including with the support of G-CSF) and PLT≥75×109/L; when myeloma cells are ≥50% , Any ANC and PLT≥50×109/L;
• Must be able to take antithrombotic drugs, such as low molecular weight heparin sodium or aspirin;
• Physical performance status (ECOG) score ≤ 2; Expected lifetime More than 3 months.
• Patients participate in the study based on his/her own will and voluntarily sign the informed consent form.

You may not qualify if:

• Patients who are allergic or intolerant to ixazomib, pomalidomide or dexamethasone;
• Patients who have used ixazomib or pomalidomide;
• Patients who are resistant to bortezomib;
• Patients with severe cardiopulmonary insufficiency;
• Patients with severe liver and kidney dysfunction, ALT or AST or bilirubin exceeds 3 times the upper limit of normal range, and the creatinine clearance rate is less than 30 ml/min;
• patients with other malignancies (except for carcinoma in situ);
• patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
• Patients with active new thrombosis or unwilling to receive anti-thrombotic therapy;
• Patients with extramedullary disease;
• Patients with peripheral neuropathy ≥ Grade 3;
• Pregnant or lactating women;
• Can't strictly contraception;
• Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up;
• Patients who have participated in other clinical trials within one month.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Jishuitan Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Peking University Third Hospital: collaborator
• Beijing Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• First Hospital of China Medical University: collaborator

Study Sites (1)

PekingUMCH

Beijing, Beijing Municipality, 100005, 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

• Junling Zhuang, MD

  Peking UMCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junling Zhuang, MD

CONTACT

13910118511; zhuangjunling@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: August 4, 2021
• Study Start: July 26, 2021
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication, the data will become available

Locations

CN (1)