NCT00185614 · REGISTRY CONDITION SEARCH

Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-01-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event-free Survival (EFS)

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outcome · POSTED

Relapse Rate

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Acute Graft-vs-Host-Disease (aGvHD)

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outcome · POSTED

Chronic Graft-vs-Host-Disease (cGvHD)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Auto-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.
intervention Names
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)
label
Auto- then Allo-HCT
type
EXPERIMENTAL

interventions

arm Group Labels
Auto- then Allo-HCT
description
The target cell dose is 2.6 x 10e6 CD34+ cells/kg
name
Autologous hematopoietic cell transplant (Auto-HCT)
type
PROCEDURE
arm Group Labels
Auto- then Allo-HCT
description
The target cell dose is 5 x 10e6 CD34 cells/kg
name
Allogeneic hematopoietic cell transplant (Allo-HCT)
type
PROCEDURE
arm Group Labels
Auto- then Allo-HCT
description
Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
name
Cyclophosphamide
other Names
Cytoxan
Neosar
type
DRUG
arm Group Labels
Auto- then Allo-HCT
description
* 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)
name
Filgrastim
other Names
Neupogen
Granulocyte-colony stimulating factor (G-CSF)
type
DRUG
arm Group Labels
Auto- then Allo-HCT
description
Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
name
Melphalan
other Names
Melphalan hydrochloride
Melphalan HCl
type
DRUG
arm Group Labels
Auto- then Allo-HCT
description
200 centigray (cGy) total body irradiation delivered on Day 0
name
Total body irradiation (TBI)
type
RADIATION
arm Group Labels
Auto- then Allo-HCT
description
Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
name
Cyclosporine (CSP)
other Names
Cyclosporine A
type
PROCEDURE
arm Group Labels
Auto- then Allo-HCT
description
Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27
name
Mycophenolate Mofetil (MMF)
other Names
CellCept
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 63
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Event-free Survival (EFS)
time Frame
3 years

secondary Outcomes

description
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).
measure
Relapse Rate
time Frame
3 years
description
Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.
measure
Overall Survival (OS)
time Frame
3 years
description
Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.
measure
Acute Graft-vs-Host-Disease (aGvHD)
time Frame
6 months
description
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).
measure
Chronic Graft-vs-Host-Disease (cGvHD)
time Frame
3 years

Full study description

brief 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; 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.
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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice