NCT00006244 · REGISTRY CONDITION SEARCH

Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced 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: 2017-07-12

This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells

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

Overall Survival

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outcome · POSTED

Initial Response to Therapy

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outcome · POSTED

Time to Disease Progression

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outcome · POSTED

Proportion of Patients Alive and in Remission

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outcome · POSTED

Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity

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outcome · POSTED

Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity

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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: * Patient must be less than 70 years old * Patients with advanced Multiple Myeloma that meet the eligibility requirements for mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or Cytoxan/G-CSF (according to protocol 506.03); if clinically indicated a lower dose of cytoxan than 4g/m2 may be used for mobilization based on the attending's discretion; also, if the patients had previously collected PBSC of sufficient number in the past and meet the other eligibility requirements, they may be entered on this study after approval by the PI * Patients with advanced Multiple Myeloma that have an identical syngeneic twin for donation of PBSCs * Patients have advanced Multiple Myeloma if they were diagnosed initially with stage II or III disease or had stage I disease that progressed after initial therapy or failed to respond to therapy * Syngeneic Donor Inclusion: * Donor and patient have adequate documentation that donor and recipient are syngeneic; including ABO typing, HLA typing and VNTR studies * Donor \> 20 kg * Donor meets eligibility to donate according to Standard Practice Guidelines Exclusion Criteria: * Patient's age \>= 70 * Karnofsky score less than 80 * A left ventricular ejection fraction less than 50%; Patients with congestive heart disease, history of myocardial infarction (MI), coronary artery disease or any arrhythmia history * Total bilirubin \> 1.5 mg/ml (unless history of Gilbert's disease) * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \> 2 x upper limit of normal * Estimated creatinine clearance \< 60 ml/min or creatinine serum \> 2.0 mg/dl * Pregnancy * Seropositivity for human immunodeficiency virus * Patients who cannot give informed consent * Secondary malignancies other than basal cell carcinoma of the skin or carcinoma in situ within the last five years * History of seizures or requirement for medicines, such as haldol, for controlling mental disorders * Concurrent need for corticosteroid therapy * Active connective tissue disease * Pleural effusion, pericardial effusion or ascites * Patients allergic to gentamicin * Patients with positive PCR for hepatitis C or hepatitis B * Patients with hypersensitivity to E. coli - derived preparations * Patients with systemic infection at time of IL2 therapy * Patients who previously have had more than 50% of their pelvic area irradiated * Patients with pulmonary function tests that show diffusion capacity (corrected) \< 60%, and/or forced expiratory volume in 1 second (FEV1) \< 65% of predicted
healthy Volunteers: false
maximum Age: 69 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: melphalan
Biological: recombinant interferon alfa
Biological: aldesleukin
Procedure: in vitro-treated peripheral blood stem cell transplantation
label
Treatment (immunotherapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (immunotherapy)
description
Given IV
name
melphalan
other Names
Alkeran
CB-3025
L-PAM
L-phenylalanine mustard
L-Sarcolysin
type
DRUG
arm Group Labels
Treatment (immunotherapy)
description
Given SC
name
recombinant interferon alfa
other Names
Alferon N
alpha interferon
IFN-A
Intron A
Roferon-A
type
BIOLOGICAL
arm Group Labels
Treatment (immunotherapy)
description
Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
name
aldesleukin
other Names
IL-2
Proleukin
recombinant human interleukin-2
recombinant interleukin-2
type
BIOLOGICAL
arm Group Labels
Treatment (immunotherapy)
description
Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
name
in vitro-treated peripheral blood stem cell transplantation
other Names
in vitro-treated PBPC transplantation
in vitro-treated PBSC
in vitro-treated peripheral blood progenitor cell transplantation
PBPC transplantation, in vitro-treated
peripheral blood progenitor cell transplantation, in vitro-treated
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 36
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.
measure
Overall Survival
time Frame
12.9 Median Years
description
Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)
measure
Initial Response to Therapy
time Frame
Evaluated at Day +84-90 Post-Transplant
measure
Time to Disease Progression
time Frame
12.9 years (median)
measure
Proportion of Patients Alive and in Remission
time Frame
12.9 Median Years

secondary Outcomes

description
Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (\< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
measure
Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
time Frame
First 100 days post-transplant
description
Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
measure
Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
time Frame
First 100 days post-transplant

Full study description

brief Summary: This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells
detailed Description: PRIMARY OBJECTIVES: I. Evaluate initial response to therapy, time to disease progression, and overall survival in MM patients treated with melphalan, IL2- incubated peripheral blood stem cells, and sequential IL2. SECONDARY OBJECTIVES: I. Evaluate grade 3-4 toxicities encountered by younger (\< 56 years old) and older (\>56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2. OUTLINE: Patients receive melphalan intravenously (IV) over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa subcutaneously (SC) 3 times a week in the absence of disease progression or unacceptable toxicity.

Source references

Source notices and limitations

Discovery and provenance

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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice