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Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma (CTd)

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ClinicalTrials.gov Identifier: NCT02248428
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yongping Zhai, Jinling Hospital, China

Brief Summary:
Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic regimens with new drugs. Clarithromycin may have partly efficacy in association with steroids and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase 3 clinical trial is proposed to explore whether clarithromycin could potentiate responsiveness of CTd (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly Diagnosed Multiple Myeloma patients. The trial will also evaluate the side effects caused by the combination of these drugs.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Clarithromycin Drug: Thalidomide Drug: Cyclophosphamide Drug: Dexamethasone Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clarithromycin Plus CTd (Cyclophosphamide,Thalidomide and Dexamethasone)Regimen for Patients With Newly Diagnosed Multiple Myeloma:a Phase 3 , Multicenter,Randomized, Open-Label Trial.
Study Start Date : April 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: 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.

Drug: Clarithromycin
500mg orally daily on days 1-28,repeated every 28 days
Other Names:
  • Abbott- 56268
  • Biaxin
  • CLARITH

Drug: Thalidomide
Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
Other Names:
  • Distaval
  • Thalomid

Drug: Cyclophosphamide
300mg/m^2 intravenously daily on day 1-3,repeated every 28 days
Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune

Drug: Dexamethasone
40 mg orally weekly on days 1,8,15,22,repeated every 28 days
Other Names:
  • Decadron
  • Aeroseb-Dex
  • Decaderm
  • DM
  • DXM

Active Comparator: 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.

Drug: Thalidomide
Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
Other Names:
  • Distaval
  • Thalomid

Drug: Cyclophosphamide
300mg/m^2 intravenously daily on day 1-3,repeated every 28 days
Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune

Drug: Dexamethasone
40 mg orally weekly on days 1,8,15,22,repeated every 28 days
Other Names:
  • Decadron
  • Aeroseb-Dex
  • Decaderm
  • DM
  • DXM




Primary Outcome Measures :
  1. Percentage of Participants With Very Good Partial Remission (VGPR) or Better [ Time Frame: up to 4 months ]
    Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction BiCTd or CTd as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.


Secondary Outcome Measures :
  1. Median Progression Free Survival (PFS) in months [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 Months ]
    PFS: Time from study entry to progression/relapse or death from study entry to death of any cause, assessed using International Myeloma Working Group Response Definitions. Progressive Disease (PD): One of the following criteria must be met: a. Increase of 25% or greater in serum M protein (absolute increase greater or equal to 0.5g/dl); b. Increase of 25% or greater in urine M protein (absolute increase greater than 200 mg/24h); c. Increase of 25% or greater in the difference between the involved and uninvolved free light chain (absolute increase greater than 10 mg/dl); d. Increase of 25% or greater in bone marrow plasma cell percentage (absolute percent greater than 5% in case the patient was in CR and 10% otherwise); i.e. Definite development of new bone lesions or soft tissue plasmacytomas, or increase in the size of existing plasmacytomas by greater or equal to 25%. Development of hypercalcemia (serum calcium > 11.5 mg/dl) attributable only to the plasma cell dyscrasia.

  2. 2 Year Overall Survival (OS) Rate [ Time Frame: up to 24 months ]
    Percentage of participants with Overall Survival in response to BiCTd or CTd in newly diagnosed multiple myeloma patients with active disease. Overall survival is time from study entry to death of any cause.

  3. Number of participants with adverse events [ Time Frame: up to 48 months ]
    Adverse events (AEs) were graded according to NCI-CTCAE Version 4.0



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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:

  • Signed informed consent form
  • 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:

  • Hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
  • 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.

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): NCT02248428


Contacts
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Contact: Yongping Zhai, doctor 13951947646 ypzhai@medmail.com.cn

Locations
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China, Jiangsu
Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Zhai, doctor    13951947646    ypzhai@medmail.com.cn   
Principal Investigator: Yongping Zhai, doctor         
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Study Chair: Yongping Zhai, doctor Jinling Hospital, China

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Responsible Party: Yongping Zhai, Department of hemotology, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02248428     History of Changes
Other Study ID Numbers: NAB20140324
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Yongping Zhai, Jinling Hospital, China:
multiple myeloma
Clarithromycin
CTd
Additional relevant MeSH terms:
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Clarithromycin
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
Thalidomide
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal