NCT00054353 · REGISTRY CONDITION SEARCH

Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With 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: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2017-10-16

This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.

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

PFS

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outcome · POSTED

Non-relapse Mortality

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outcome · POSTED

Incidence of Acute GVHD (Grades III-IV)

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outcome · POSTED

Incidence of Chronic (Extensive) GVHD

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outcome · POSTED

OS

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outcome · POSTED

Engraftment

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outcome · POSTED

Relapse Rate

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outcome · POSTED

Response Rate

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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: Inclusion Criteria: * Meet Salmon and Durie criteria for initial diagnosis of MM; transplant will be offered to patients with previously treated MM who meet one of the following criteria: * Patient received at least one prior autologous or syngeneic hematopoietic SCT (HSCT) and now has progressive disease (PD) (greater than 25% increase in serum or urine paraprotein levels compared to best response status after autograft or appearance of new lytic bone lesions or plasmocytomas) * Patient is not able to collect autologous PBSC due to poor marrow reserve (insufficient HSC-mobilization: \< 2.5 x 10\^6 cluster of differentiation \[CD\]34+ cells/kg); or contraindications to undergoing HSC-mobilization; patient now has PD and has received at least 4 cycles of standard chemotherapy (e.g. vincristine sulfate, doxorubicin hydrochloride, and dexamethasone \[VAD\]) in the past * Patients must have the capacity to give informed consent * DONOR: Human leukocyte antigen (HLA) genotypically identical sibling or phenotypically matched relative * DONOR: HLA phenotypically matched unrelated donor (according to Standard Practice HLA matching criteria) * Matched for serologically recognized HLA-A or B or C antigens and at least five of six HLA-A or B or C alleles * Matched for HLA DRB1 and DQB1 alleles (defined by high-resolution typing) at the allele level * DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for PBSC collection * DONOR: Donor must have adequate veins for leukapheresis or agree to placement of a temporary central venous catheter Exclusion Criteria: * Karnofsky score \< 60% * Left ventricular ejection fraction \< 40% or symptomatic heart failure; ejection fraction is required if age \> 50 years or there is a history of anthracycline exposure or history of cardiac disease * Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL,or symptomatic biliary disease * Diffusion capacity of carbon monoxide (DLCO) \< 50% (corrected) or receiving continuous supplemental oxygen * Creatinine clearance \< 40 mL/min * Patients with poorly controlled hypertension * Seropositive for the human immunodeficiency virus (HIV) * Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \> 20% risk of disease recurrence * Pregnancy or breastfeeding * Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment * Not fully recovered from previous high-dose therapy: * Persistent mucositis and gastrointestinal symptoms requiring hyperalimentation and/or intravenous hydration * On steroids for autologous/syngeneic GVHD * On IV antibiotics for documented infections * Cytomegalovirus (CMV)-antigenemia positive * On ganciclovir or foscarnet for previous CMV reactivation/infection; off of this therapy for less than two weeks despite documented CMV-antigenemia- negativity (identification \[ID\] should be consulted if there is persistent CMV antigenemia post autograft) * Ongoing radiotherapy * Patients who meet any of these criteria may be discussed with the principal investigator for recommendations as to the timing of the allograft * Patients with active bacterial or fungal infections unresponsive to medical therapy * DONOR: Identical twin * DONOR: Donors unwilling to donate PBSC * DONOR: Pregnancy * DONOR: Infection with HIV * DONOR: Inability to achieve adequate venous access * DONOR: Known allergy to G-CSF * DONOR: Current serious systemic illness * DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation * DONOR: Age \< 12 years * DONOR: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
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
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).
intervention Names
Drug: fludarabine phosphate
Drug: melphalan
Radiation: total-body irradiation
Drug: mycophenolate mofetil
Drug: cyclosporine
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis
label
Related Donor
type
EXPERIMENTAL
description
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).
intervention Names
Drug: fludarabine phosphate
Drug: melphalan
Radiation: total-body irradiation
Drug: mycophenolate mofetil
Drug: cyclosporine
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis
label
Unrelated Donor
type
EXPERIMENTAL

interventions

arm Group Labels
Related Donor
Unrelated Donor
description
Given IV
name
fludarabine phosphate
other Names
2-F-ara-AMP
Beneflur
Fludara
type
DRUG
arm Group Labels
Related Donor
Unrelated Donor
description
Given IV
name
melphalan
other Names
Alkeran
CB-3025
L-PAM
L-phenylalanine mustard
L-Sarcolysin
type
DRUG
arm Group Labels
Related Donor
Unrelated Donor
description
Undergo TBI
name
total-body irradiation
other Names
TBI
type
RADIATION
arm Group Labels
Related Donor
Unrelated Donor
description
Given PO
name
mycophenolate mofetil
other Names
Cellcept
MMF
type
DRUG
arm Group Labels
Related Donor
Unrelated Donor
description
Given PO
name
cyclosporine
other Names
ciclosporin
cyclosporin
cyclosporin A
CYSP
Sandimmune
type
DRUG
arm Group Labels
Related Donor
Unrelated Donor
description
Undergo reduced-intensity allogeneic PBSCT
name
nonmyeloablative allogeneic hematopoietic stem cell transplantation
type
PROCEDURE
arm Group Labels
Related Donor
Unrelated Donor
description
Undergo reduced-intensity allogeneic PBSCT
name
peripheral blood stem cell transplantation
other Names
PBPC transplantation
PBSC transplantation
peripheral blood progenitor cell transplantation
transplantation, peripheral blood stem cell
type
PROCEDURE
arm Group Labels
Related Donor
Unrelated Donor
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 16
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas.
measure
PFS
time Frame
At 1 year post-transplant
description
Early NRM will be monitored in a sequential fashion.
measure
Non-relapse Mortality
time Frame
At day 100
description
Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.
measure
Incidence of Acute GVHD (Grades III-IV)
time Frame
Up to 5 years
description
Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.
measure
Incidence of Chronic (Extensive) GVHD
time Frame
Up to 5 years

secondary Outcomes

description
Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.
measure
OS
time Frame
At 6 months and then every year thereafter, up to 5 years
description
Number of subjects who engrafted post-transplant. Engraftment will be monitored in a sequential fashion.
measure
Engraftment
time Frame
Up to 5 years
description
Number of subjects who relapsed after achieving CR post-transplant. Relapse rate will be summarized using cumulative incidence estimates.
measure
Relapse Rate
time Frame
Up to 5 years
description
Number of subjects who achieved CR post-transplant. Response rate will be summarized using cumulative incidence estimates.
measure
Response Rate
time Frame
Up to 5 years

Full study description

brief Summary: This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.
detailed Description: PRIMARY OBJECTIVES: I. To evaluate the efficacy of this approach by determining the 1-year progression-free survival (PFS) and overall survival (OS). II. To evaluate day 100 non-relapse mortality. III. To determine the incidences of grades II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD. OUTLINE: PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or thrice daily (TID) on days 0-40 with taper to day 96 (unrelated donors). After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months, and then annually thereafter for 5 years.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice