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AzTrials

Blood CancerPhase 2NCT00185614

Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

A Phase 2 study testing Autologous hematopoietic cell transplant (Auto-HCT), Allogeneic hematopoietic cell transplant (Allo-HCT) and Cyclophosphamide in people with Blood Cancer and Multiple Myeloma, run by Wen-Kai Weng 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
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Trial summary

Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Blood Cancer, Multiple Myeloma
What is being tested?
Autologous hematopoietic cell transplant (Auto-HCT), Allogeneic hematopoietic cell transplant (Allo-HCT) and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited States
Study dates
Aug 2000to Apr 2010
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

PATIENT INCLUSION CRITERIA

  • Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease
  • Patient has HLA-identical sibling donor
  • Age ≤ 70 years
  • No prior therapy which would preclude the use of low-dose total body irradiation
  • Pathology review and diagnosis confirmation by Stanford University Medical Center
  • Karnofsky performance status (KPS) > 70%
  • DLCO ≥ 60% predicted
  • ALT and AST < 2 x upper limit of normal (ULN)
  • Total bilirubin < 2 mg/dL
  • Serum creatinine < 2.0, or 24-hour creatinine clearance ≥ 60 mL/min
  • HIV-negative
  • Signed informed consent document

PATIENT EXCLUSION CRITERIA

  • Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis
  • Severe psychological or medical illness
  • Prior allogeneic hematopoietic cell transplantation
  • Pregnant or lactating

ALLOGENEIC DONOR INCLUSION CRITERIA

  • Age ≥ 17
  • HIV-seronegative
  • Signed informed consent document

ALLOGENEIC DONOR EXCLUSION CRITERIA

  • Serious medical or psychological illness
  • Pregnant or lactating
  • Prior malignancies within the last 5 years, except for non-melanoma skin cancers

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.

Read the detailed description

Participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (auto-HCT)]. Post-infusion support includes filgrastim 5 µg/kg/day, starting 6 days following melphalan. Participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic HCT (allo-HCT). For allo-HCT, a sibling donor that is fully matched for human leukocyte antigen (HLA-matched) is identified. Participants receive a single dose of total body irradiation (TBI) 200 centigray (cGy) as well as immunosuppression with cyclosporine (CSP) 6.25 mg/kg and mycophenolate mofetil (MMF) 15 mg/kg. The HLA-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to Day 0, with apheresis collections on Day -1 and Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV and diphenhydramine 50 mg IV. CSP will be tapered beginning Day 56 with a goal of discontinuing CSP on Day 180, adjusted as needed.

Being tested
Autologous hematopoietic cell transplant (Auto-HCT), Allogeneic hematopoietic cell transplant (Allo-HCT), Cyclophosphamide, Filgrastim, Melphalan
Medical subject headings
Hematologic Neoplasms, Multiple Myeloma

What participants receive

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

  • Autologous hematopoietic cell transplant (Auto-HCT)Procedure or surgery

    The target cell dose is 2.6 x 10e6 CD34+ cells/kg

  • Allogeneic hematopoietic cell transplant (Allo-HCT)Procedure or surgery

    The target cell dose is 5 x 10e6 CD34 cells/kg

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar

    Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion

  • FilgrastimDrug

    Also called Neupogen, Granulocyte-colony stimulating factor (G-CSF)

    • Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT)
    • Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT)
    • Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)

  • MelphalanDrug

    Also called Melphalan hydrochloride, Melphalan HCl

    Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT

  • Total body irradiation (TBI)Radiation

    200 centigray (cGy) total body irradiation delivered on Day 0

  • Cyclosporine (CSP)Procedure or surgery

    Also called Cyclosporine A

    Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56

  • Mycophenolate Mofetil (MMF)Drug

    Also called CellCept

    Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27

Study groups in NCT00185614
Study groupRoleWhat they receive
Auto- then Allo-HCTExperimentalAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
Receives: Procedure: Autologous hematopoietic cell transplant (Auto-HCT); Procedure: Allogeneic hematopoietic cell transplant (Allo-HCT); Drug: Cyclophosphamide; Drug: Filgrastim; Drug: Melphalan; Radiation: Total body irradiation (TBI); Procedure: Cyclosporine (CSP); Drug: Mycophenolate Mofetil (MMF)

What is being measured

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

  1. Event-free Survival (EFS)

    Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.

    Measured: 3 years

Secondary outcomes (4)

  1. Relapse Rate

    Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase).

    Measured: 3 years

  2. Overall Survival (OS)

    Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.

    Measured: 3 years

  3. Acute Graft-vs-Host-Disease (aGvHD)

    Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.

    Measured: 6 months

  4. Chronic Graft-vs-Host-Disease (cGvHD)

    Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria).

    Measured: 3 years

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startAug 2000
  3. Primary completionApr 2009
  4. Study completionApr 2010

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00185614
Sponsor's protocol ID
IRB-13378
Other IDs
75190, BMT109
Status last verified
Jan 2018
First submitted
12 Sep 2005
Last updated
18 Jan 2018
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous hematopoietic cell transplant (Auto-HCT), Allogeneic hematopoietic cell transplant (Allo-HCT) and Cyclophosphamide in people with Blood Cancer and Multiple Myeloma, run by Wen-Kai Weng 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?

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 18 Jan 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 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 18 Jan 2018). 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?

Event-free Survival (EFS) (time frame: 3 years). 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 NCT00185614.

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 18 Jan 2018.

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