NCT00349778 · REGISTRY CONDITION SEARCH

High-Dose Sequential Therapy and Single Autologous Transplantation 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
Status at capture: COMPLETED
Registry last update: 2017-12-12

This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.

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 With Pulmonary Toxicity

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outcome · POSTED

Overall Participant Survival (OS)

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outcome · POSTED

Number of Participants That Relapse After Autologous Transplantation

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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 * Stage II to III multiple myeloma, or progression after initial treatment of Stage I disease; early or relapsed * Age 18 to 75 years. * Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. * Patients with amyloidosis may be eligible for this trial, with approval by the Principle Investigator. * Patients must have a Karnofsky performance status \> 70%. * Aspartate aminotransferase (AST) must be \< 2 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) must be \< 2 x ULN * Total bilirubin \< 2 mg/dL. * Serum creatinine \< 2.0 or 24-hour creatinine clearance ≥ 60 mL/min. * Patients must be HIV-negative. * Patients must provide signed, informed consent. EXCLUSION CRITERIA * Severe psychological or medical illness * Prior autologous hematopoietic cell transplantation * Pregnant * Lactating women * Smoldering multiple myeloma, * Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded from this study
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
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
intervention Names
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Melphalan
Drug: Carmustine
Drug: Filgrastim
label
High-Dose Sequential Therapy
type
EXPERIMENTAL

interventions

arm Group Labels
High-Dose Sequential Therapy
description
Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in \~250 mL of saline or D5W and infused IV over 2 hours
name
Cyclophosphamide
other Names
Cytoxan
Neosar
type
DRUG
arm Group Labels
High-Dose Sequential Therapy
description
100 mg etoposide as 5 mL solution in clear ampules for injection.
name
Etoposide
other Names
Etopophos
VePesid
Toposar
VP-16
Etoposide phosphate
type
DRUG
arm Group Labels
High-Dose Sequential Therapy
description
Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.
name
Melphalan
other Names
Alkeran
L-PAM
L-Sarcolysin
Phenylalanine mustard
type
DRUG
arm Group Labels
High-Dose Sequential Therapy
description
Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.
name
Carmustine
other Names
BiCNU
BCNU
type
DRUG
arm Group Labels
High-Dose Sequential Therapy
description
Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
name
Filgrastim
other Names
Neupogen
Granulocyte-colony stimulating factor (G-CSF)
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 102
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.
measure
Number of Participants With Pulmonary Toxicity
time Frame
2 years

secondary Outcomes

description
Survival status was assessed 5 years after transplant.
measure
Overall Participant Survival (OS)
time Frame
5 years
description
Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation
measure
Number of Participants That Relapse After Autologous Transplantation
time Frame
5 years

Full study description

brief Summary: This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.
detailed Description: Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of carmustine. Institutional experience in myeloma patients using this dose of carmustine indicates an incidence of IP of34%. There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival. Our results with high-dose sequential therapy including the dose-intense carmustine/melphalan transplant demonstrates similar median EFS and overall survival (OS) when compared with the results of tandem transplant approaches.The proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of IP.

Source references

references

citation
Chen AI, Negrin RS, McMillan A, Shizuru JA, Johnston LJ, Lowsky R, Miklos DB, Arai S, Weng WK, Laport GG, Stockerl-Goldstein K. Tandem chemo-mobilization followed by high-dose melphalan and carmustine with single autologous hematopoietic cell transplantation for multiple myeloma. Bone Marrow Transplant. 2012 Apr;47(4):516-21. doi: 10.1038/bmt.2011.106. Epub 2011 May 23.
pmid
21602899
type
RESULT

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice