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Clarithromycin,Lenalidomide and Dexamethasone for Relapsed/Refractory Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02986451
Recruitment Status : Withdrawn
First Posted : December 8, 2016
Last Update Posted : August 14, 2018
China Food and Drug Administration
Information provided by (Responsible Party):
wanghua, Sun Yat-sen University

Brief Summary:
This phase II study investigating the efficacy and safety of a combination of biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.

Condition or disease Intervention/treatment Phase
Relapse/Refractory Multiple Myeloma Drug: clarithromycin Drug: Lenalidomide Drug: Dexamethasone Phase 2

Detailed Description:
The combination of lenalidomide and dexamethasone is effective in increasing the response rate, time to progression, and overall survival in patients with relapsed or refractory myeloma.Clarithromycin is an antibiotic that has shown efficacy in association with steroids and lenalidomide.Clarithromycin, lenalidomide and dexamethasone (BiRd) in newly diagnosed MM has yielded an overall response rates (ORR) of 93% and a progression-free survival (PFS) of 43 months.No prospective study of BiRd to treat relapsed or refractory myeloma has been reported so far.The goal of this phase 2 clinical trial was to assess the response rate and toxicity of a combination regimen of clarithromycin (Biaxin), lenalidomide (Revlimid), and dexamethasone (BiRD) for the treatment of relapsed/refractory MM.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of BiRD (Biaxin [Clarithromycin]/Revlimid [Lenalidomide]/Dexamethasone) Combination Therapy in Relapsed/Refractory Myeloma
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Intervention
All patients received clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Dexamethasone (40 mg) was given orally on days 1, 8, 15, and 22. Clarithromycin (500 mg) was given orally twice daily.Lenalidomide (25 mg) was given orally daily on days 1 to 21
Drug: clarithromycin
Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle.
Other Name: Biaxin

Drug: Lenalidomide
Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
Other Name: Revlimid

Drug: Dexamethasone
Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle.
Other Name: hexadecadrol

Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 30 months ]
    ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 30 months ]
    PFS, defined as time from first dose of study treatment to progression or death due to any cause, as assessed by investigator

  2. Overall survival (OS) [ Time Frame: 30 months ]
    OS, defined as time from first dose of study treatment to death

  3. Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments [ Time Frame: 30 months ]
    Safety of combination therapy (Clarithromycin,lenalidomide and dexamethasone) as assessed by toxicity, which will be assessed using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale for Adverse Events and for laboratory assessments (v4.03) that include biochemistry, hematology, urinalysis; special safety assessments that include LVEF, Thyroid function Creatinine clearance and ECGs (electrocardiograms).

  4. Genomic Predictors of Response Rate and PFS [ Time Frame: 30 months ]
    Blood (about 1-2 tablespoons) collected for biomarker and routine tests and to evaluate the ORR and PFS.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has a previous diagnosis of multiple myeloma
  • Patient requires retreatment for multiple myeloma
  • Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI
  • Subject has a Karnofsky performance status ≥60% (>50% if due to bony involvement of myeloma (see Appendix IV)
  • Subject has a life expectancy ≥ 3 months
  • Subjects must meet the following laboratory parameters:

Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Hemoglobin ≥ 7 g/dL Platelet count ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration) Serum SGOT/AST <3.0 x upper limits of normal (ULN) Serum SGPT/ALT <3.0 x upper limits of normal (ULN) Serum total bilirubin <2.0 mg/dL (34 µmol/L) Creatinine clearance ≥ 30 cc/min

Exclusion Criteria:

  • Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning)
  • Subject has a prior history of other malignancies unless disease-free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels
  • Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA (New York Hospital Association) Class III or IV heart failure (see Appendix VI), Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Female subject who is pregnant or lactating
  • Subject has known HIV infection
  • Subject has known active hepatitis B or hepatitis C infection
  • Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program
  • Subject is unable to reliably take oral medications
  • Subject has known hypersensitivity to dexamethasone,cyclophosphamide,paclitaxel
  • Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment
  • Subject has any clinically significant medical or psychiatric disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

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 identifier (NCT number): NCT02986451

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China, Guangdong
Sun Yat-sen University Cancer Center
GuangZhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
China Food and Drug Administration
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Principal Investigator: zhongjun xia, MD. hematological oncology department
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Responsible Party: wanghua, professor, Sun Yat-sen University Identifier: NCT02986451    
Other Study ID Numbers: MM-2016
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors