NCT00222105 · REGISTRY CONDITION SEARCH

A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

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: 2017-07-02

Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.

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 Response Rate

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outcome · POSTED

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: * Patients with active, symptomatic multiple myeloma without prior chemotherapy: * Durie-Salmon Stage II-III A/B * Stage I patients with at least 2 of the poor prognostic indicators may be eligible. * Patients with plasma cell leukemia * Non-secretory multiple myeloma patients are eligible * Patients between the ages of 18 and 75 years old * Female Patients of child bearing age (up to age 50) who are not pregnant and agree to use two adequate birth control methods during the study and at least six months after treatment unless patient has undergone hysterectomy or has been in menopause for 2 years. * Patients with Southwest Oncology Group (SWOG) performance status of 3 or better * Patients who have received prior lower dose Dexamethasone Therapy (ie. 4 mg QID) as adjunct to radiation therapy for cord compression may be eligible * All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater than or equal to 50% within 42 days prior to registration * Must be able to understand English. * Must be willing and eligible to sign up for the STEPS program Exclusion Criteria: * Nursing mothers or women who are pregnant * Patients with a history of hypersensitivity reaction to doxorubicin or agents in Doxil® * Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years. * History of mediastinal radiation for any reason * History of receiving prior anthracyclines * Patients with uncontrolled medical problems such as diabetes mellitus, cardiac, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma * Myocardial infarction within 6 months of enrollment in the study. * Major surgery within 4 weeks of enrollment. * Patients previously treated or receiving other treatment for multiple myeloma other than lower doses dexamethasone as adjunct to radiotherapy * Pre-existing peripheral neuropathy * Patients with previously diagnosed malabsorption syndromes or anatomical abnormalities of the gastrointestinal tract that result in malabsorption syndromes. * Patients with a history of cardiac disease, defined as New York Heart Association Class II or greater, or clinical evidence of congestive heart failure. * Patients with psychiatric or central nervous systems disorders interfering with compliance of orally administered medication. * Patients currently receiving anticoagulant therapy for venous thromboembolic episode or other hypercoagulable states. * Patients who are unable to understand the English language.
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
Doxil, Thalidomide, Dexamethasone
intervention Names
Drug: Doxil
Drug: Thalidomide
Drug: Dexamethasone
label
1
type
EXPERIMENTAL

interventions

arm Group Labels
1
description
Doxil 40 mg/m2 IV day 1
name
Doxil
other Names
pegylated liposomal doxorubicin
type
DRUG
arm Group Labels
1
description
50-100 mg day 1-28
name
Thalidomide
other Names
thalidomid
type
DRUG
arm Group Labels
1
description
Dexamethasone 40 mg day 1-4 and 15-18
name
Dexamethasone
other Names
decadron
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 25
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.
measure
Overall Response Rate
time Frame
At End of Cycle 1, 28 Days

secondary Outcomes

description
Count of Participants with adverse events.
measure
Toxicity
time Frame
End of study, up to 12 months

Full study description

brief Summary: Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.
detailed Description: Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects. This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.

Source references

Source notices and limitations

Discovery and provenance

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