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Relapse/Refractory Multiple MyelomaPhase 2NCT02985333

Paclitaxel,Cyclophosphamide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing Paclitaxel, Cyclophosphamide and Dexamethasone in people with Relapse/Refractory Multiple Myeloma, run by Sun Yat-sen University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Relapse/Refractory Multiple Myeloma
What is being tested?
Paclitaxel, Cyclophosphamide and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Jan 2014to Jun 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Read the 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

Keywords
paclitaxe,cyclophosphamide,dexamethasone, Multiple Myeloma
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol

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

  • CyclophosphamideDrug

    Also called cytoxan

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

  • DexamethasoneDrug

    Also called hexadecadrol

    Dexamethasone 20mg iv d1-4

Study groups in NCT02985333
Study groupRoleWhat they receive
InterventionExperimentalpaclitaxel 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.
Receives: Drug: Paclitaxel; Drug: Cyclophosphamide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 months

Secondary outcomes (3)

  1. Progression Free Survival (PFS)

    PFS, defined as time from first dose of study treatment to progression or death due to any cause, as assessed by investigator

    Measured: 30 months

  2. Overall survival (OS)

    OS, defined as time from first dose of study treatment to death

    Measured: 30 months

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

    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).

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985333
Sponsor's protocol ID
MM-2014
Status last verified
Dec 2016
First submitted
5 Dec 2016
Last updated
14 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Cyclophosphamide and Dexamethasone in people with Relapse/Refractory Multiple Myeloma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02985333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.

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