NCT00177047 · REGISTRY CONDITION SEARCH

Autologous Transplant for 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, PHASE3
Status at capture: COMPLETED
Registry last update: 2021-11-09

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

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

Number of Participants Achieving a Complete Response

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outcome · POSTED

Number of Participants Achieving a Complete Response

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outcome · POSTED

Number of Participants Achieving a Complete Response

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outcome · POSTED

Number of Patients With Extended Disease-free Survival

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outcome · POSTED

Number of Participants With Overall Survival

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outcome · POSTED

Number of Participants With Overall Survival

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outcome · POSTED

Number of Participants With Overall Survival

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outcome · POSTED

Count of Participants Experiencing Transplant Related Mortality

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outcome · POSTED

Number of Participants Experiencing Incidence of Relapse

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outcome · POSTED

Number of Participants With Disease Progression

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outcome · POSTED

Time to Progression

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outcome · POSTED

Time to Relapse

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outcome · POSTED

Number of Participants With Absolute Neutrophil Recovery

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outcome · POSTED

Time to Attainment of CR

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outcome · POSTED

Time to Attainment of CR+PR

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outcome · POSTED

Duration of Maintenance Treatment

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outcome · POSTED

Dropout Rate From Maintenance Therapy

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outcome · POSTED

Number of Participants With Toxicities

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outcome · POSTED

Number of Participants With Infections

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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: * Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following: * After initial therapy in either first complete or partial remission or no objective response * After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response * Is not eligible or has refused any protocols of higher priority * 18 - 75 years of age * Adequate organ function defined as: * Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused) * Cardiac: no active ischemia, left ventricular ejection fraction \> 45% by MUGA scan * Hepatic: bilirubin \< 2.0 mg/dl, ALT \< 3x the upper limit of normal * Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) \>50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) \> 50% predicted * Performance status: Karnofsky performance of \> 80%. * Free of active uncontrolled infection at the time of study entry. * At time of study enrollment \> 4 weeks from prior myelosuppressive chemotherapy; and \> 6 weeks from prior nitrosoureas. * Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee. Exclusion Criteria: * Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens. * Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
intervention Names
Procedure: Stem Cell Transplant
Drug: Cyclophosphamide + Mesna
Drug: Melphalan
Biological: Granulocyte-colony stimulating factor
label
Chemotherapy and Transplant Treatment
type
EXPERIMENTAL

interventions

arm Group Labels
Chemotherapy and Transplant Treatment
description
As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
name
Stem Cell Transplant
other Names
Bone Marrow Transplant
type
PROCEDURE
arm Group Labels
Chemotherapy and Transplant Treatment
description
Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
name
Cyclophosphamide + Mesna
other Names
Cytoxan
type
DRUG
arm Group Labels
Chemotherapy and Transplant Treatment
description
Administered intravenously 200 mg/m\^2
name
Melphalan
other Names
Alkeran
type
DRUG
arm Group Labels
Chemotherapy and Transplant Treatment
description
Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
name
Granulocyte-colony stimulating factor
other Names
G-CSF
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 363
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
measure
Number of Participants Achieving a Complete Response
time Frame
100 Days post transplant
description
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
measure
Number of Participants Achieving a Complete Response
time Frame
6 months post transplant
description
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
measure
Number of Participants Achieving a Complete Response
time Frame
12 months post transplant

secondary Outcomes

description
Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.
measure
Number of Patients With Extended Disease-free Survival
time Frame
36 Months
description
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
measure
Number of Participants With Overall Survival
time Frame
1 year
description
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
measure
Number of Participants With Overall Survival
time Frame
2 years
description
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
measure
Number of Participants With Overall Survival
time Frame
3 years
description
In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
measure
Count of Participants Experiencing Transplant Related Mortality
time Frame
1 year
description
The return of disease after its apparent recovery/cessation.
measure
Number of Participants Experiencing Incidence of Relapse
time Frame
1 year
description
Myeloma Response Definitions - Using International Uniform Response Criteria: Progressive Disease (PD) For patients not in CR or sCR, progressive disease requires one or more of the following: * \>25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL. * \>25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours. * Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl), only in patients without measurable paraprotein in the serum and urine. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
measure
Number of Participants With Disease Progression
time Frame
1 year
description
Mean number of days among patients progressing
measure
Time to Progression
time Frame
1 year
description
Mean number of days among patients relapsing
measure
Time to Relapse
time Frame
1 year
description
Hematologic recovery is defined by absolute neutrophil count (ANC) \>2500/μl and platelets \> 100,000/μl
measure
Number of Participants With Absolute Neutrophil Recovery
time Frame
Day 42
description
Mean (STD) among patients achieving complete remission (CR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas
measure
Time to Attainment of CR
time Frame
12 months post transplant
description
Mean (STD) among patients achieving complete remission (CR) and partial remission (PR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas. Partial Response (PR): * Greater than or equal to 50% reduction in the level of the serum monoclonal paraprotein and/or reduction in 24 hour urinary monoclonal paraprotein either by greater than or equal to 90% or to \<200 mg/24 hours in light chain disease. * If the only measurable non-bone marrow parameter is FLC, greater than or equal to 50% reduction in the difference between involved and uninvolved FLC levels or a 50% decrease in level
measure
Time to Attainment of CR+PR
time Frame
12 months post transplant

Full study description

brief Summary: This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
detailed Description: Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice