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

Sponsor

The First Hospital of Jilin University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04063189

Collaborator

(none)

100

Enrollment

Location

Arm

34.4

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma in Relapse	Drug: Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 21, 2017

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) [Every 2 months until disease progression or study completion，an average of 2 year]
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 [Through study completion,an average of 2 year]
According to NCI-CTCAE version 4.03
Progression-Free Survival (PFS) [Through study completion, an average of 2 year]
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
Overall Survival (OS) [Through study completion, an average of 2 year]
OS were calculated from the time of enrollment to death or the last follow-up
Duration of Response (DOR) [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

Other Outcome Measures

Health-Related Quality of Life (HRQoL) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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