Clarithromycin,Lenalidomide and Dexamethasone for Relapsed/Refractory Myeloma

NCT02986451 | Withdrawn Phase 2

• 1 other identifier: MM-2016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapse/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment

  30 months

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  30 months

• Overall survival (OS)

  30 months

• Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments

  30 months

• Genomic Predictors of Response Rate and PFS

  30 months

Study Arms (1)

Intervention

EXPERIMENTAL

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; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

clarithromycin DRUG

Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle.

Also known as: Biaxin

Intervention

Lenalidomide DRUG

Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle

Also known as: Revlimid

Intervention

Dexamethasone DRUG

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

Also known as: hexadecadrol

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• China Food and Drug Administration: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

Clarithromycin; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• zhongjun xia, MD.

  hematological oncology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)