Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma

NCT02248428 | Unknown Phase 3 DMC

• 1 other identifier: NAB20140324
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; Clarithromycin; CTd

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Very Good Partial Remission (VGPR) or Better

  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.

  up to 4 months

Secondary Outcomes (3)

• Median Progression Free Survival (PFS) in months

  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

• 2 Year Overall Survival (OS) Rate

  up to 24 months

• Number of participants with adverse events

  up to 48 months

Study Arms (2)

BiCTd regimen

EXPERIMENTAL

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; Drug: Thalidomide; Drug: Cyclophosphamide; Drug: Dexamethasone

CTd regimen

ACTIVE COMPARATOR

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; Drug: Cyclophosphamide; Drug: Dexamethasone

Interventions

Clarithromycin DRUG

500mg orally daily on days 1-28,repeated every 28 days

Also known as: Abbott- 56268, Biaxin, CLARITH

BiCTd regimen

Thalidomide DRUG

Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days

Also known as: Distaval, Thalomid

BiCTd regimen; CTd regimen

Cyclophosphamide DRUG

300mg/m\^2 intravenously daily on day 1-3,repeated every 28 days

Also known as: Endoxan, Cytoxan, Neosar, Procytox, Revimmune

BiCTd regimen; CTd regimen

Dexamethasone DRUG

40 mg orally weekly on days 1,8,15,22,repeated every 28 days

Also known as: Decadron, Aeroseb-Dex, Decaderm, DM, DXM

BiCTd regimen; CTd regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Clarithromycin; Thalidomide; Cyclophosphamide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Yongping Zhai, doctor

  Jinling Hospital, China

  STUDY CHAIR

Central Study Contacts

Yongping Zhai, doctor

CONTACT

13951947646; ypzhai@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of hemotology

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: April 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

CN (1)