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Multiple MyelomaPhase 2NCT02112045

A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation

A Phase 2 study testing Granix, High dose melphalan (HDR) and Autologous Stem Cell Transplant (ASCT) in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Granix, High dose melphalan (HDR) and Autologous Stem Cell Transplant (ASCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
20 Jan 2015to 10 Sep 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic multiple myeloma requiring treatment
  • Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy
  • At least 18 years of age
  • Adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved, peripheral blood stem cell collection containing at least 2 × 10^6 CD34+ cells/kg based on patient body weight.
  • Adequate organ function as measured by:
  • Cardiac function: Left ventricular ejection fraction at rest ≥40%
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  • Hepatic function: Bilirubin ≤2 × ULN and aspartate amino transferase/alanine amino transferase (AST/ALT) ≤3 × ULN
  • Renal function: Creatinine clearance ≥40 mL/minute (measured or calculated/estimated)
  • Pulmonary function: Carbon monoxide diffusing capacity (DLCO; corrected for hemoglobin [Hgb]), forced expiratory volume in 1 second (FEV1), forced expiratory vital capacity (FVC) ≥50% of predicted value
  • Oxygen saturation ≥92% on room air
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Able to understand and willing to sign an IRB-approved written informed consent document

Who cannot join

  • Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior to ASCT
  • Prior stem cell transplant (autologous or allogeneic)
  • Smoldering MM not requiring therapy
  • Plasma cell leukemia
  • Systemic amyloid light chain amyloidosis
  • Active bacterial, viral, or fungal infection
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  • Seropositive for human immunodeficiency virus (HIV)
  • Known, active hepatitis A, B, or C Infection
  • Pregnant or breastfeeding.
  • Receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the ASCT or planning to receive any of these treatments prior to the last study visit on Day +100.
  • Hypersensitive or intolerant to any component of the study drug(s) formulation
  • Receiving growth factors (filgrastim, XM02-filgrastim, peg-filgrastim, plerixafor, etc) or undergoing apheresis < 14 days prior to the start of treatment on protocol (Day -7).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation

This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may help multiple myeloma cells move from the patient's bone marrow to the blood where they may be more sensitive to treatment with melphalan. It is not yet known whether adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in treating multiple myeloma

Being tested
Granix, High dose melphalan (HDR), Autologous Stem Cell Transplant (ASCT)
Medical subject headings
Multiple Myeloma

What participants receive

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

  • GranixDrug

    Also called XM02 filgrastim

  • High dose melphalan (HDR)Drug

    Also called Alkeran® Tablets, Phenylalanine mustard

  • Autologous Stem Cell Transplant (ASCT)Procedure or surgery

Study groups in NCT02112045
Study groupRoleWhat they receive
Experimental: Granix and high dose melphalan (HDM)ExperimentalGranix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
Receives: Drug: Granix; Drug: High dose melphalan (HDR); Procedure: Autologous Stem Cell Transplant (ASCT)
Control: High dose melphalan (HDM)Active comparatorHDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0.
Receives: Drug: High dose melphalan (HDR); Procedure: Autologous Stem Cell Transplant (ASCT)

What is being measured

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

  1. Number of Participants With Complete Response or Stringent Complete Response

    Complete response (CR) requires all of the following:

    • Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine
    • <5% plasma cells in the bone marrow
    • Disappearance of soft tissue plasmacytomas

    Stringent complete response (sCR) requires all of the following:

    • CR as defined above
    • Normal free light chain ratio
    • Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence

    Measured: Day +100

Secondary outcomes (6)

  1. Number of Participants With Adverse Events

    -Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: Up through Day 30

  2. Number of Participants With Overall Response

    Overall response rate=CR+sCR+VGPR+PR

    Complete response (CR), disappearance of monoclonal protein from the blood \& urine and <5% plasma cells in bone marrow \&disappearance of soft tissue plasmacytomas

    Stringent complete response (sCR), CR \& normal free light chain ratio \& absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence

    Very good partial response (VGPR), serum and urine monoclonal protein detectable by immunofixation but not on electrophoresis OR > 90% reduction in serum monoclonal protein with urine monoclonal protein < 100 mg per 24 hours and if present, > 50% reduction in the size of soft tissue plasmacytomas

    Partial response (PR), > 50% reduction in the level of the serum monoclonal protein \& reduction in urine monoclonal protein \& > 50% reduction in the size of soft tissue plasmacytomas \& if serum and urine monoclonal protein are unmeasurable and serum free light chain is unmeasurable, a > 50% reduction in plasma cells is required

    Measured: Up to 2 years

  3. Overall Survival as Measured by Number of Participants Alive at Last Follow-up

    OS is defined as the duration from the time of transplant Day 0 to death or last follow-up.

    Measured: Up to 2 years

  4. Progression-free Survival as Measured by Number of Participants Without Disease Progression at Last Follow-up

    PFS is defined as the duration from time of transplant Day 0 to time of first progression/clinical relapse, death, or the date the patient was last known to be in remission

    Measured: Up to 2 years

  5. Number of Participants With Neutrophil Engraftment

    Neutrophil engraftment is defined as ANC ≥ 0.5 × 10^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which ANC ≥ 0.5 × 109/L will be recorded as the date of neutrophil engraftment. Time to neutrophil engraftment will be calculated as the time from the date of the ASCT to the date of neutrophil engraftment.

    Measured: Up to Day 30

  6. Number of Participants With Platelet Engraftment

    Platelet engraftment is defined as an untransfused platelet measurement >20,000/mm3 × 3 consecutive daily assessments. The first of 3 consecutive days for which the untransfused platelet measurement is >20,000/mm3 will be recorded as the date of platelet engraftment. Time to platelet engraftment will be calculated as the time from receiving the date of ASCT to the date of platelet engraftment. Untransfused is defined as no transfusions within 7 days.

    Measured: Up to Day 100

Timeline

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

  1. First posted11 Apr 2014 (estimated)
  2. Study start20 Jan 2015
  3. Primary completion13 Dec 2017
  4. Study completion10 Sep 2019

Why it stopped: Terminated due to results of interim analysis

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112045
Sponsor's protocol ID
201405057
Status last verified
Nov 2019
First submitted
4 Apr 2014
Last updated
26 Nov 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Granix, High dose melphalan (HDR) and Autologous Stem Cell Transplant (ASCT) in people with Multiple Myeloma, run by Washington University School of Medicine 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 12 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: stopped early, as of the sponsor's last update on 26 Nov 2019. 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 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?

Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Complete Response or Stringent Complete Response (time frame: Day +100). 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 NCT02112045.

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 26 Nov 2019.

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