Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma

August 17, 2019 updated by: FengYan Jin, The First Hospital of Jilin University

A Prospective, Multicenter, Single Arm, Phase II Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone (BiRd Regimen) in the Treatment of the First Relapsed Multiple Myeloma

BiRd regimen consisting of clarithromycin and Rd is safe and effective in NDMM. It can significantly increase ORR (up to 90.3%) , relief depth (≥VGPR), and prolong PFS to 43 months. In our previous study, thirty RRMM patients treated with BiRd regimen in 6 centers in China benefited.It suggested that BiRd regimen may not only improve overall efficacy of RRMM , especially long-term benefits, but also reverse Rd resistance in patients who fail to achieve any remission after multiline therapy.The study is a Prospective, Multicenter, Single Arm, Phase II Clinical Trial, which intend to recruit first relapse MM patients over 18 years old. Once included, patients will receive the treatment of Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen. (Clarithromycin 500mg，po，bid，d1-21; Lenalidomide 25mg，po，daily，d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg，po，daily，d1-2, 8-9,15-16, 22-23) And we will evaluate efficacy and adverse events of the BiRd regimen at a point of time predetermined.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. diagnosed as symptomatic multiple myeloma.
  2. the first relapse/progression with thalidomide, bortezomib or lenalidomide based current first-line treatment or resistance to the first-line treatment (previous treatment line number =1).
  3. there must be measurable lesions to determine disease progression (PD): according to the IMWG 2016 efficacy evaluation criteria.
  4. the expected survival time is longer than 3 months.
  5. ECOG score less than 2 points.
  6. the serum AST/ALT level <3 times higher than the normal value; the serum total bilirubin level<2 times of the normal value; creatinine clearance rate was ≥30ml/mi.
  7. neutrophil count >1000/mm3 ; platelet count >75000/mm3 (if bone marrow plasma cell <50%) or >30000/mm3 (if the plasma cells in the bone marrow is not less than 50%).
  8. women of childbearing age were negative for pregnancy before admission, and agreed to carry out pregnancy screening during the study (once a month until 4 weeks after the last dose), and agreed to use contraceptive measures within 3 months after the study and the last dose.
  9. all patients were required to sign informed consent.

Exclusion Criteria:

  1. under the age of 18
  2. ECOG score >2
  3. non secretory myeloma, defined as serum protein M < 1g/dL, urinary M protein < 200mg/24h and sFLCR ≤100mg/L
  4. there is growing demand, pregnant or lactating women within one year
  5. HIV infection
  6. activity of HBV or HCV infection
  7. 4 weeks before entering the group of thromboembolic events
  8. not signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: First Relapsed Multiple Myeloma
Drug: Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen
Clarithromycin 500mg，po，bid，d1-21; Lenalidomide 25mg，po，daily，d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg，po，daily，d1-2, 8-9,15-16, 22-23

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Every 2 months until disease progression or study completion，an average of 2 year
According to the criteria of IMWG 2016
Every 2 months until disease progression or study completion，an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v4.03
Time Frame: Through study completion,an average of 2 year
According to NCI-CTCAE version 4.03
Through study completion,an average of 2 year
Progression-Free Survival (PFS)
Time Frame: Through study completion, an average of 2 year
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
Through study completion, an average of 2 year
Overall Survival (OS)
Time Frame: Through study completion, an average of 2 year
OS were calculated from the time of enrollment to death or the last follow-up
Through study completion, an average of 2 year
Duration of Response (DOR)
Time Frame: Through study completion, an average of 2 year
the time from the first assessment of CR (complete response) or PR (partial response) to the first PD (Progressive Disease) or any cause of death
Through study completion, an average of 2 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (HRQoL)
Time Frame: Every 6 months until disease progression or study completion，an average of 2 year
According to the data of SF-36 Quality of Life Questionnaire Survey
Every 6 months until disease progression or study completion，an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

  • Study Director: Fengyan Jin, professor, The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2017

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

August 17, 2019

First Posted (ACTUAL)

August 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 17, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BiRd 2017-288-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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