Paclitaxel,Cyclophosphamide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

May 8, 2018 updated by: wanghua, Sun Yat-sen University

Efficacy and Safety of Paclitaxel/Cyclophosphamide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple MyelomaRefractory

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Paclitaxel
Paclitaxel 170 mg/m(2) IV over 3 h d1
Other Names:
  • Taxol
Drug: Cyclophosphamide
Cyclophosphamide 200mgmg/m(2) IV d1,3,5
Other Names:
  • cytoxan
Drug: Dexamethasone
Dexamethasone 20mg iv d1-4
Other Names:
  • hexadecadrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 months
Overall survival (OS)
Time Frame: 30 months
OS, defined as time from first dose of study treatment to death
30 months
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 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).
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: yue lu, MD., hematological oncology department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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