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Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217967
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborators:
Peking University Third Hospital
Beijing Jishuitan Hospital
Beijing Chao Yang Hospital
Xuanwu Hospital, Beijing
Peking University First Hospital
Jilin Provincial Tumor Hospital
Shanxi Dayi Hospital
Information provided by (Responsible Party):
Junling Zhuang, Peking Union Medical College Hospital

Brief Summary:
The purpose of this study is to evaluate the real-world efficacy and safety of ixazomib, lenalidomide, or ixazomib in combination with lenalidomide as maintenance therapy in patients with newly diagnosed multiple myeloma in China.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Ixazomib Drug: Lenalidomide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Prospective Study of Ixazomib, Lenalidomide, and Ixazomib in Combination With Lenalidomide for Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma
Actual Study Start Date : January 3, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022


Arm Intervention/treatment
Active Comparator: Lenalidomide group
lenalidomide 25mg qod d1~21 days, rest 7 days
Drug: Lenalidomide
the lenalidomide group uses lenalidomide as comparitor group and the combination group receives both lenalidomide and ixazomib

Active Comparator: Ixazomib group
ixazomib 4mg orally, once a week, 3 times a month
Drug: Ixazomib
the ixazomib group uses ixazomib as the comparator group, the combination group receives both lenalidomide and ixazomib as the experimental group

Experimental: Combination group
ixazomib 4mg orally, once a week, 3 times a month lenalidomide 25mg qod d1~21 days, rest 7 days use in combination
Drug: Ixazomib
the ixazomib group uses ixazomib as the comparator group, the combination group receives both lenalidomide and ixazomib as the experimental group

Drug: Lenalidomide
the lenalidomide group uses lenalidomide as comparitor group and the combination group receives both lenalidomide and ixazomib




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: From date of enrollment until the date of first documented progression, assessed up to 20 months ]
    from enrollment to first disease progression

  2. overall survival [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
    from enrollment to death with follow-up

  3. time to next treatment [ Time Frame: From date of enrollment until the next treatment, assessed up to 24 months ]
    from enrollment to the time next treatment is administrated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age older than 18 years;
  2. Newly diagnosed MM patients who fulfill the diagnostic criteria of International Myeloma Working Group (IMWG) 2014 standard;
  3. Maintenance treatment will start after first-line treatment or second-line treatment;
  4. The total courses of front-line regimens are between 4-9. Autologous transplantation is considered as consolidation treatment;
  5. The clinical efficacy before the enrollment is partial response (PR) or better;
  6. Physical performance status (ECOG) score ≤ 2;
  7. Patients participate in the study based on his/her own will and voluntarily sign the informed consent form

Exclusion Criteria:

  1. Patients who are allergic or intolerant to ixazomib or lenalidomide;
  2. patients with severe cardiopulmonary dysfunction;
  3. patients with severe hepatic insufficiency, ALT or bilirubin more than 2 times the upper limits of normal range;
  4. patients with other malignancies (except for carcinoma in situ);
  5. patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
  6. pregnant or lactating women;
  7. can not be strictly contraceptive;
  8. Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217967


Contacts
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Contact: Junling Zhuang, MD +86 13910118511 zhuangjunling@hotmail.com

Locations
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China, Beijing
PekingUMCH Recruiting
Beijing, Beijing, China, 100005
Contact: Junling Zhuang, MD    +86 13910118511    zhuangjunling@hotmail.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Peking University Third Hospital
Beijing Jishuitan Hospital
Beijing Chao Yang Hospital
Xuanwu Hospital, Beijing
Peking University First Hospital
Jilin Provincial Tumor Hospital
Shanxi Dayi Hospital
Investigators
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Principal Investigator: Junling Zhuang, MD Peking Union Medical College, department of hematology
Publications:

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Responsible Party: Junling Zhuang, Associate professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04217967    
Other Study ID Numbers: ZS-2129
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: individual baseline characteristic, treatment and follow-up results will be shared after publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After publication, the data will become available

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Junling Zhuang, Peking Union Medical College Hospital:
real-world
dual-drug maintenance
oral regimen
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Ixazomib
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action