AzTrials
AzTrials

Refractory Multiple MyelomaPhase 1NCT01074060

Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma

A Phase 1 study testing plerixafor, filgrastim and cyclophosphamide in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: There are different methods of stem cell mobilization, such as using colony-stimulating factors alone or following chemotherapy priming. More recently, the combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell mobilization. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
plerixafor, filgrastim and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Apr 2010to Feb 2013
Phase
Phase 1
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible to undergo autologous transplantation
  • Diagnosed with multiple myeloma (MM)
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
  • The patient has recovered from all acute toxic effects of prior chemotherapy
  • White Blood Count (WBC) > 2.5 x 10^9/L
  • Absolute neutrophil count >1.5 x 10^9/L
Show all 18Show fewer
  • Platelet count > 100 x 10^9/L
  • Serum creatinine <= 2.5 mg/dl
  • Creatinine clearance >= 50 ml/min (measured or calculated)
  • Serum glutamic oxaloacetic transaminase (SGOT) < 2 x ULN (Upper Limit of Normal)
  • Serum glutamic pyruvic transaminase (SGPT) < 2 x ULN
  • Total bilirubin < 2 x ULN
  • Left ventricle ejection fraction > 45% [by normal ECHO (Echocardiogram) or MUGA (MUltiple Gated Acquisition) scan]
  • FEV1 (forced expiratory volume in 1 second) > 60% of predicted or DLCO (Carbon Monoxide Diffusing Capacity )> 55% of predicted
  • No active infection of hepatitis B or C
  • Negative for HIV
  • Signed informed consent (may be obtained anytime prior to admission for cytoxan)
  • Women of child bearing potential agree to use an approved form of contraception

Who cannot join

  • A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
  • A residual acute medical condition resulting from prior chemotherapy
  • Brain metastases or carcinomatous meningitis
  • Acute infection
  • Fever (temp > 38 degrees C/100.4 degrees F)
  • Positive pregnancy test in female patients
Show all 16Show fewer
  • Lactating females
  • Patients of child-bearing potential unwilling to implement adequate birth control
  • Prior treatment with Plerixafor
  • Prior stem cell transplant, either autologous or allogeneic
  • Prior cyclophosphamide priming
  • Heart rate < 50 at screening
  • Abnormal ECG (electrocardiogram) with a clinically significant rhythm disturbance or conduction abnormality that in the opinion of the investigator warrants exclusion of the subject from the trial
  • Patients with congestive heart failure at screening
  • History of atrial fibrillation
  • Patients who are currently on medication to control cardiac arrhythmias

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma

RATIONALE: There are different methods of stem cell mobilization, such as using colony-stimulating factors alone or following chemotherapy priming. More recently, the combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell mobilization. This study will assess whether the combination of plerixafor and Granulocyte Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with cyclophosphamide.

PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor following cyclophosphamide priming.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and tolerability of intravenous(IV) PLERIXAFOR when given in combination with cyclophosphamide and G-CSF as a mobilization regimen in patients with Multiple Myeloma.

SECONDARY OBJECTIVES:

  1. To determine if intravenous PLERIXAFOR, given with a cyclophosphamide and G-CSF mobilizing regimen, will allow collection of greater than or equal to 5 x 10^6 CD34+ cells/kg in 2 or less apheresis days.

II. To review the timing of intravenous plerixafor administration prior to apheresis and describe our experience.

OUTLINE:

MOBILIZATION: Patients receive cyclophosphamide intravenously (IV). Patients also receive filgrastim subcutaneously (SC) daily beginning approximately 24 hours later.

TREATMENT/APHERESIS: Beginning 10 days after cyclophosphamide, patients receive plerixafor IV over 30 minutes followed by filgrastim SC on each day of apheresis.

Following the collection of an adequate number of stem cells, patients undergo high-dose chemotherapy and autologous stem cell rescue. Patients are followed post-autologous stem cell transplant for engraftment.

After completion of study treatment, patients are followed periodically.

Being tested
plerixafor, filgrastim, cyclophosphamide, autologous hematopoietic stem cell transplantation, laboratory biomarker analysis
Medical subject headings
Multiple Myeloma

What participants receive

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

  • plerixaforDrug

    Also called AMD 3100, LM-3100, Mozobil

    Given IV

  • filgrastimBiological

    Also called G-CSF, granulocyte colony-stimulating factor, Neupogen, r-metHuG-CSF

    Given SC

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • autologous hematopoietic stem cell transplantationProcedure or surgery

    autologous hematopoietic stem cell transplantation

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01074060
Study groupRoleWhat they receive
Arm IExperimentalMOBILIZATION: Patients receive cyclophosphamide IV. Patients also receive filgrastim subcutaneously (SC) daily beginning approximately 24 hours later. TREATMENT/APHERESIS: Beginning 10 days after cyclophosphamide, patients receive plerixafor IV over 30 minutes followed by filgrastim SC on each day of apheresis.
Receives: Drug: plerixafor; Biological: filgrastim; Drug: cyclophosphamide; Procedure: autologous hematopoietic stem cell transplantation; Other: laboratory biomarker analysis

What is being measured

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

  1. To assess the MTD ( maximum tolerated dose) of IV plerixafor when given post cyclophosphamide and GCSF for stem cell priming.Dose limiting toxicity will be defined as any grade 3 or 4 nonhematologic toxicity.

    Measured: 12 to 18 months

  2. Tolerability and safety of PLERIXAFOR

    Will be summarized in terms of type, severity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0), date of onset, duration, reversibility, and attribution.

    Measured: 6 months post transplant

Secondary outcomes (5)

  1. Frequency of collecting 5 x 10^6 or more CD34+ cells/kg in 2 or less apheresis days

    Measured: 5 days post apheresis completion

  2. Percentage of plasma cells

    Measured: 5 days post apheresis

  3. Completion of 100 days post-transplant

    Measured: 100 days post-transplant

  4. Overall and disease-free survival

    Measured: 6months and one year post transplant

  5. Time to engraftment

    Measured: 6 months post transplant

Timeline

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

  1. First posted24 Feb 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01074060
Sponsor's protocol ID
08186
Other IDs
NCI-2010-00160
Status last verified
Feb 2013
First submitted
19 Feb 2010
Last updated
15 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing plerixafor, filgrastim and cyclophosphamide in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by City of Hope Medical Center at 1 site in United States.

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 18 inclusion and 16 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: finished, as of the sponsor's last update on 15 Feb 2013. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To assess the MTD ( maximum tolerated dose) of IV plerixafor when given post cyclophosphamide and GCSF for stem cell priming.Dose limiting toxicity will be defined as any grade 3 or 4 nonhematologic toxicity. (time frame: 12 to 18 months). The study lists 2 primary outcomes in all. 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 NCT01074060.

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 15 Feb 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in