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

Primary Purpose

Multiple Myeloma in Relapse

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen

About this trial

This is an interventional treatment trial for Multiple Myeloma in Relapse focused on measuring Clarithromycin Lenalidomide Dexamethasone Regimen, Treatment Response, Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosed as symptomatic multiple myeloma.
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).
there must be measurable lesions to determine disease progression (PD): according to the IMWG 2016 efficacy evaluation criteria.
the expected survival time is longer than 3 months.
ECOG score less than 2 points.
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.
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%).
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.
all patients were required to sign informed consent.

Exclusion Criteria:

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

Sites / Locations

The First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

First Relapsed Multiple Myeloma

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate (ORR)

According to the criteria of IMWG 2016

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v4.03

According to NCI-CTCAE version 4.03

Progression-Free Survival (PFS)

PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death

Overall Survival (OS)

OS were calculated from the time of enrollment to death or the last follow-up

Duration of Response (DOR)

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

Full Information

NCT ID

NCT04063189

First Posted

January 17, 2018

Last Updated

August 17, 2019

Sponsor

The First Hospital of Jilin University

1. Study Identification

Unique Protocol Identification Number

NCT04063189

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 21, 2017 (Actual)

Primary Completion Date

February 1, 2020 (Anticipated)

Study Completion Date

February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma in Relapse

Keywords

Clarithromycin Lenalidomide Dexamethasone Regimen, Treatment Response, Survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

First Relapsed Multiple Myeloma

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

According to the criteria of IMWG 2016

Time Frame

Every 2 months until disease progression or study completion，an average of 2 year

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v4.03

Description

According to NCI-CTCAE version 4.03

Time Frame

Through study completion,an average of 2 year

Title

Progression-Free Survival (PFS)

Description

PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death

Time Frame

Through study completion, an average of 2 year

Title

Overall Survival (OS)

Description

OS were calculated from the time of enrollment to death or the last follow-up

Time Frame

Through study completion, an average of 2 year

Title

Duration of Response (DOR)

Description

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

Time Frame

Through study completion, an average of 2 year

Other Pre-specified Outcome Measures:

Title

Health-Related Quality of Life (HRQoL)

Description

According to the data of SF-36 Quality of Life Questionnaire Survey

Time Frame

Every 6 months until disease progression or study completion，an average of 2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosed as symptomatic multiple myeloma. 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). there must be measurable lesions to determine disease progression (PD): according to the IMWG 2016 efficacy evaluation criteria. the expected survival time is longer than 3 months. ECOG score less than 2 points. 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. 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%). 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. all patients were required to sign informed consent. Exclusion Criteria: under the age of 18 ECOG score >2 non secretory myeloma, defined as serum protein M < 1g/dL, urinary M protein < 200mg/24h and sFLCR ≤100mg/L there is growing demand, pregnant or lactating women within one year HIV infection activity of HBV or HCV infection 4 weeks before entering the group of thromboembolic events not signed informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fengyan Jin, professor

Phone

13844989638

fengyanjin@jlu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fengyan Jin, professor

Organizational Affiliation

The First Hospital of Jilin University

Official's Role

Study Director

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fengyan Jin, Professor

Phone

+8613844989638

fengyanjin@jlu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

21410373

Citation

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27986429

Citation

Agarwal A, Chow E, Bhutani M, Voorhees PM, Friend R, Usmani SZ. Practical Considerations in Managing Relapsed Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2017 Feb;17(2):69-77. doi: 10.1016/j.clml.2016.11.010. Epub 2016 Nov 23.

Results Reference

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

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Citation

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

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