Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma
NCT ID: NCT02248428
Last Updated: 2017-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
130 participants
INTERVENTIONAL
2012-04-30
2020-09-30
Brief Summary
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Detailed Description
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The participants are randomly equally selected to receive BiCTd regimen arm or CTd regimen arm. The treatment consists of eight induction and consolidation therapy followed by maintenance therapy.
BiCTd(Clarithromycin, Cyclophosphamide, Thalidomide and Dexamethasone) regimen arm：
Induction and consolidation Phase:
All patients will also receive aspirin 100mg PO QD while receiving BiCTd. Aspirin will continue through maintenance.
Clarithromycin 500 mg orally daily on days 1-28,thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m\^2 intravenously on day 1-3. Eight Cycles were repeated every 28 days.
If efficacy \<PR after 4 cycles of induction， or disease progression at anytime，patients will be quitted.
Maintenance Therapy:
Patients who complete the induction and consolidation regimen could be started on maintenance therapy as follows: Maintenance with CP (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) regimen until disease progression.
CTd regimen arm：
Induction and consolidation Phase:
All patients will also receive aspirin 100mg PO QD while receiving CTd. Aspirin will continue through maintenance.
Thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m\^2 intravenously on day 1-3. Eight Cycles were repeated every 28 days.
If efficacy \<PR after 4 cycles of induction， or disease progression at anytime，patients will be quitted.
If no further reduction in the serum and urine M protein in the next cycle，patients may cross over to BiCTd regimen.
Maintenance Therapy:
Patients who complete the induction and consolidation regimen could be started on maintenance therapy as follows: Maintenance with CP (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) regimen until disease progression Then, patients will be followed up for 24 months after chemotherapy. The investigators will record all the laboratory and clinical investigations to assess response at different points of the study. We also assess adverse events (AEs), as graded according to NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0.Response categories were based on the International Myeloma Working Group uniform response criteria.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BiCTd regimen
Induction and consolidation therapy: BiCTd regimen for 8 cycles. Patients received Clarithromycin 500 mg orally on days 1-28,thalidomide 100-200mg orally on days d1-28, dexamethasone 40mg orally on days on 1,8,15,22, and cyclophosphamide 300mg/m\^2 intravenously on day 1-3. Cycles were repeated every 28 days.
Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) until disease progression.
If efficacy \<PR after 4 cycles of induction or disease progression at anytime，patients will be quitted.
Clarithromycin
500mg orally daily on days 1-28,repeated every 28 days
Thalidomide
Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
Cyclophosphamide
300mg/m\^2 intravenously daily on day 1-3,repeated every 28 days
Dexamethasone
40 mg orally weekly on days 1,8,15,22,repeated every 28 days
CTd regimen
Induction and consolidation therapy: CTd regimen for 8 cycles. Patients received thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m\^2 intravenously on day 1-3. Cycles were repeated every 28 days.
Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,28 Days per Cycle) until disease progression.
If efficacy \<PR after 4 cycles of induction or disease progression at anytime，patients will be quitted.
If no further reduction in the serum and urine M protein in the next cycle，patients may cross over to BiCTd regimen.
Thalidomide
Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
Cyclophosphamide
300mg/m\^2 intravenously daily on day 1-3,repeated every 28 days
Dexamethasone
40 mg orally weekly on days 1,8,15,22,repeated every 28 days
Interventions
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Clarithromycin
500mg orally daily on days 1-28,repeated every 28 days
Thalidomide
Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
Cyclophosphamide
300mg/m\^2 intravenously daily on day 1-3,repeated every 28 days
Dexamethasone
40 mg orally weekly on days 1,8,15,22,repeated every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to adhere to the study visit schedule and other protocol requirements
* Diagnosed with active multiple myeloma
* Previously untreated
* Karnofsky performance status(KPS) ≥50（KPS\<50 will be allowed if related to bony disease）
* New York Heart Association(NYHA) functional ≤class III
Exclusion Criteria
* Concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
* A history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin.
* Impaired renal function,Creatinine ≥221umol/L；
* Pregnant or breast feeding females.
* Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
18 Years
ALL
No
Sponsors
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Jinling Hospital, China
OTHER
Responsible Party
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Yongping Zhai
Department of hemotology
Principal Investigators
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Yongping Zhai, doctor
Role: STUDY_CHAIR
Jinling Hospital, China
Locations
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Jinling Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NAB20140324
Identifier Type: -
Identifier Source: org_study_id
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