NCT00097981 · REGISTRY CONDITION SEARCH

A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed 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: PHASE3
Status at capture: COMPLETED
Registry last update: 2017-04-07

The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.

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

Complete Response Rate: Number of Participants Who Achieved a Complete Response

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outcome · POSTED

Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)

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outcome · POSTED

Time to 1st Response

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outcome · POSTED

Time to Progression

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outcome · POSTED

Overall Survival: Number of Participants Died Due to Any Cause

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outcome · POSTED

Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)

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outcome · POSTED

Engraftment: Number of Participants Who Underwent Engraftment

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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: * Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group \[IMWG\] criteria * Eastern Cooperative Oncology Group (ECOG) status 0-2 * Adequate absolute neutrophil count (ANC), platelet count and hemoglobin * Adequate serum calcium * Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.) Exclusion Criteria: * No treatment with dexamethasone for multiple myeloma * No peripheral neuropathy of Grade 2 or higher * No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage * No history of life-threatening thromboembolic events of any kind (ie, myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study * No deep vein thrombosis (DVT) within 1 year of enrollment * No current anticoagulation for DVT
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Thalidomide
Drug: Dexamethasone
label
Thalidomide + dexamethasone
type
ACTIVE_COMPARATOR
intervention Names
Drug: Thalidomide
Drug: Dexamethasone
Drug: DOXIL
label
Thalidomide + dexamethasone + DOXIL
type
EXPERIMENTAL

interventions

arm Group Labels
Thalidomide + dexamethasone
Thalidomide + dexamethasone + DOXIL
description
Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.
name
Thalidomide
type
DRUG
arm Group Labels
Thalidomide + dexamethasone
Thalidomide + dexamethasone + DOXIL
description
Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.
name
Dexamethasone
type
DRUG
arm Group Labels
Thalidomide + dexamethasone + DOXIL
description
DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.
name
DOXIL
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 225
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.
measure
Complete Response Rate: Number of Participants Who Achieved a Complete Response
time Frame
From Cycle 2 until 28 days following completion of treatment

secondary Outcomes

description
Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
measure
Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
time Frame
From Cycle 2 until 28 days following completion of treatment
description
Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
measure
Time to 1st Response
time Frame
From Cycle 2 until 28 days following completion of treatment
description
Time to progression is the interval between the date of randomization until disease progression or death due to progression.
measure
Time to Progression
time Frame
From randomization until death or as assessed up to 2 years post last participant last treatment visit
measure
Overall Survival: Number of Participants Died Due to Any Cause
time Frame
From randomization until death or as assessed up to 2 years post last participant last treatment visit
measure
Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)
time Frame
From randomization until death or as assessed up to 2 years post last participant last treatment visit
description
Engraftment is the process of transplanted stem cells reproducing new cells.
measure
Engraftment: Number of Participants Who Underwent Engraftment
time Frame
From randomization until death or as assessed up to 2 years post last participant last treatment visit

Full study description

brief Summary: The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.
detailed Description: This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4 to 12 treatment cycles, depending on the response of their multiple myeloma to the treatment (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection). Maximum duration of study participation for each participant will be 48 weeks.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice