Paclitaxel,Cyclophosphamide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

NCT ID: NCT02985333

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-06-30

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of paclitaxel in combination with cyclophosphamide and dexamethasone in chinese patients with relapsed/refractory multiple myeloma.

Detailed Description

Treatment for relapsed/refractory multiple myeloma (MM)remains a crucial challenge.The investigators have previously shown that the combination of paclitaxel and cyclophosphamide acts synergistically to induce apoptosis of myeloma cells in vitro. Based on these preclinical studies, the investigators initiated a phase II clinical trial of paclitaxel 175 mg/m(2) IV over 3 h d1 combined with cyclophosphamide 200 mg/m(2) IV over 30-60 min d1,3,5 and dexamethasone 20mg IV over 30-60 min d1-4 in patients with relapsed or refractory MM. This regimen was administered every four weeks for a total of six cycles

Conditions

Relapse/Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

paclitaxel 175 mg/m(2) IV over 3 h d1,cyclophosphamide 200 mg/m(2) IV d1,3,5 and dexamethasone 20mg IV d1-4 in patients with relapsed or refractory MM.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Paclitaxel 170 mg/m(2) IV over 3 h d1

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide 200mgmg/m(2) IV d1,3,5

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20mg iv d1-4

Interventions

Paclitaxel

Paclitaxel 170 mg/m(2) IV over 3 h d1

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide 200mgmg/m(2) IV d1,3,5

Intervention Type: DRUG

Dexamethasone

Dexamethasone 20mg iv d1-4

Intervention Type: DRUG

Other Intervention Names

Taxol; cytoxan; hexadecadrol

Eligibility Criteria

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 ≥ 45 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

wanghua

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yue lu, MD.

Role: PRINCIPAL_INVESTIGATOR

hematological oncology department

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

MM-2014

Identifier Type: -

Identifier Source: org_study_id