NCT00793650 · REGISTRY CONDITION SEARCH

Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study

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: TERMINATED
Registry last update: 2012-08-30

The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.

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

Safety and Engraftment

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outcome · POSTED

Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.

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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 with multiple myeloma who are eligible for an autologous peripheral blood progenitor transplant * Male and female subjects between the age of 18 and 70 years. * Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care * Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. * Male subjects agrees to use an acceptable method for contraception for the duration of the study. * Biopsy proven diagnosis of multiple myeloma from bone marrow aspirate and biopsy prior to study initiation * Patient has achieved less than 90% disease reduction from previous treatment prior to transplant (as measured by serum or urine protein electrophoresis) and has more than 5% plasma cells in the bone marrow, or patient has progressed and has more than 5% plasma cells in the bone marrow. * Karnofsky Performance Status score of ≥ 60% * Patient has met the following laboratory requirements prior to Day -4 * Platelet count ≥ 50, 000/mm3 * Absolute Neutrophil Count ≥ 500/mm3 * Hemoglobin ≥ 10 g/dL (transfusion allowed to meet this criterion) * Calculated creatinine clearance ≥ 30mL/min * Toxic effects of previous therapy or surgery resolved to Grade 2 or better Exclusion Criteria: * Unsupportable anemia with \< 10b/dL * Patient has a calculated or measured creatinine clearance of \< 30mL/min within 14 days before enrollment * Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment * Patient has hypersensitivity to bortezomib, boron or mannitol * Patient has had an allergic reaction to melphalan or chlorambucil * Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Patient has received other investigational drugs with 14 days before enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Cardiac or pulmonary dysfunction such that patients do not meet institutional pre-transplant evaluation criteria * Known central nervous system involvement or suspicion of involvement with Myeloma * Other active malignancies (with the exception of basal and squamous cell skin cancer) within 5 years of study entry. Patients with treated prostate or cervical cancer in situ who are 2 or more years from therapy and remain free of disease may be entered into the study at the investigator's discretion. * Known to be HIV positive, HIV-1 positive
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan.
intervention Names
Drug: Bortezomib
Drug: Melphalan
Procedure: Autologous PBSC Transplant
label
Bortezomib before Melphalan
type
ACTIVE_COMPARATOR
description
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.
intervention Names
Drug: Bortezomib
Drug: Melphalan
Procedure: Autologous PBSC Transplant
label
Bortezomib after Melphalan
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Bortezomib after Melphalan
Bortezomib before Melphalan
description
Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.
name
Bortezomib
other Names
Bortezomib or Velcade
type
DRUG
arm Group Labels
Bortezomib after Melphalan
Bortezomib before Melphalan
description
All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2.
name
Melphalan
other Names
Bortezomib or Velcade
type
DRUG
arm Group Labels
Bortezomib after Melphalan
Bortezomib before Melphalan
description
Day 0 consists of the stem cell infusion.
name
Autologous PBSC Transplant
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 39
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10\^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.
measure
Safety and Engraftment
time Frame
Day 30 after transplant

secondary Outcomes

description
CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 hour. Partial Response:\>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200mg per 24 hour.
measure
Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.
time Frame
100 days after transplant

Full study description

brief Summary: The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice