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MyelomaPhase 2NCT02027220

Combination of G-CSF, Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Multiple Myeloma

A Phase 2 study testing G-CSF, Bortezomib and Cyclophosphamide in people with Myeloma and Bortezomib, run by Second Affiliated Hospital of Soochow University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Bortezomib may stop the growth of myeloma cells by blocking proteasome activity. Cyclophosphamide and dexamethasone may work in different ways to stop the growth of myeloma cells by stopping them from dividing or by killing the cells. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myeloma, Bortezomib, Cyclophosphamide
What is being tested?
G-CSF, Bortezomib and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Dec 2013to Dec 2015
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

  • Male or female, aged ≥18 years, ≤ 80 years.
  • Newly diagnosed multiple myeloma according to International Myeloma Working Group.
  • Relapsed or bortezomib resistant multiple myeloma (MM), who didn't received bortezomib during the last line of therapy for MM prior to this study.
  • Progressive disease according to International Myeloma Working Group.
  • Negative pregnancy test for female with reproductive ability.
  • Signed written informed consent.

Who cannot join

  • The patient has a history of other active malignancies within 3 years prior to study entry.
  • The patient exhibits evidence of clinically significant uncontrolled conditions including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal).
  • Female patient is pregnant or breast-feeding.
  • Known infection with HIV, active Hepatitis B or Hepatitis C.
  • The patient has a history of prior toxicity from bortezomib, cyclophosphamide or dexamethasone that resulted in permanent discontinuation of treatments.
  • Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration.
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  • Uncontrolled hypertension (defined as systolic blood pressure[BP] > 160 millimeters of mercury (mmHg) or diastolic BP > 100mmHg).
  • Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association function Class Ⅲ or Ⅳ prior to study drug administration.
  • System illness or other severe concurrent disease or alcoholism, which, in the judgement of the investigator, would make inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of investigational treatments.
  • Known or suspected of not being able to comply with the trial protocol.
  • Having been previously enrolled in this clinical trial.
  • -

Trial locations and contacts

1 site in 1 country.

jinxiang fu, Doctor contact

86-512-67784-66

lbzwz0907@hotmail.com

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

    jinxiang fu, doctor, 86-512-67784066, lbzwz0907@hotmail.com

    jinxiang fu, doctor

    Recruiting

Other trials in China

About this study

Official title: Phase Ⅱ Study of G-CSF, Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Multiple Myeloma

RATIONALE: Bortezomib may stop the growth of myeloma cells by blocking proteasome activity. Cyclophosphamide and dexamethasone may work in different ways to stop the growth of myeloma cells by stopping them from dividing or by killing the cells. Granulocyte Clone Stimulating Factor (G-CSF) possesses the ability to mobilize the plasma cells to detach from myeloma niche, so as to promote drug sensitivity.

PURPOSE: This phase Ⅱ trial is to study how well combination of G-CSF, bortezomib, cyclophosphamide and dexamethasone works in treating patients with multiple myeloma.

Read the detailed description

Myeloma cells reside in specialised microenvironments, which is called myeloma niche. Myeloma niche provides important cell-cell interactions and signalling molecules that regulate localization and proliferation of myeloma cells. stromal cell-derived factor 1(SDF-1)/Chemokine (C-X-C Motif) Receptor 4 (CXCR4) plays an important role in this process. G-CSF is reported to induce stem cell mobilization by decreasing bone marrow SDF-1. Our in vitro study found that G-CSF enhanced bortezomib activity by inhibiting SDF-1/CXCR4. Myeloma patients treated with Bortezomib, Cyclophosphamide and Dexamethasone have achieved a relatively good response, with an ORR about 80% and complete remission about 40%. We hypothesized that G-CSF may mobilize myeloma cells from myeloma niches thus to enhance bortezomib activity.

Medical subject headings
Neoplasms, Plasma Cell

What participants receive

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

  • G-CSFDrug

    G-CSF Intracutaneous injection (IC) on days 0, 1, 7, 8, 14, 15, 21 and 22, every four weeks.

  • BortezomibDrug

    Also called Velcade

    Bortezomib Intravenous injection (IV) on days 1, 8, 15 and 22, every four weeks.

  • CyclophosphamideDrug

    Cyclophosphamide, Continuously Intravenous injection (CIV) on days 1, 8, 15 and 22, every four weeks.

  • DexamethasoneDrug

    Dexamethasone Intravenous injection (IV) on days 1, 2, 8, 9, 15, 16, 22 and 23, every four weeks.

Study groups in NCT02027220
Study groupRoleWhat they receive
G-CSF/Bortez/Cyc/DexExperimentalG-CSF IC on days 0, 1, 7, 8, 14, 15, 21 and 22. Bortezomib IV on days 1, 8, 15 and 22. Cyclophosphamide CIV on days 1, 8, 15 and 22. Dexamethasone IV on days 1, 2, 8, 9, 15, 16, 22 and 23.
Receives: Drug: G-CSF; Drug: Bortezomib; 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)

    Defined as the portion of patients whose best response is equal to or better than partial response (PR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to International Myeloma Working Group (IMWG). Response was confirmed after every cycle of treatment. Stringent complete response (sCR): Normal free light chain (FLC) ration, plus criteria for complete response. Complete response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in the bone marrow. Very Good Partial Response(VGPR): Positive immunofixation but negative electrophoresis; ≥90% reduction in serum M-component; Urine M-component ≤ 100mg per 24 hours. Partial Response (PR): ≥50% reduction in serum M-component and/or Urine M-component ≥90% reduction or < 200mg per 24 hours.

    Measured: 4 months

Secondary outcomes (4)

  1. Number of participants with treatment related adverse events.

    Adverse Events (AE) are assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 3.0. The maximum grade for each type of AE will be recorded for each patient. Grade 1: Mild AE. Grade 2: Moderate AE. Grade 3: Severe AE. Grade 4: Life-threatening or disabling AE. Grade 5: Death related AE.

    Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  2. Overall Survival (OS)

    Survival time is defined as the time from registration to death due to any cause.

    Measured: 2 years

  3. Progression Free Survival (PFS)

    PFS is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death.

    Measured: 2 years

  4. Duration of Response (DOR)

    Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.

    Measured: 2 years

Timeline

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

  1. First posted6 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02027220
Sponsor's protocol ID
GBCD-001
Status last verified
Jan 2014
First submitted
21 Dec 2013
Last updated
6 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing G-CSF, Bortezomib and Cyclophosphamide in people with Myeloma and Bortezomib, run by Second Affiliated Hospital of Soochow 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Jan 2014. 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?

Results are not available in the source record.

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

Contact jinxiang fu, Doctor (86-512-67784-66, lbzwz0907@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 4 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 NCT02027220.

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 6 Jan 2014.

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