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Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00049673
Enrollment
332
Registered
2003-01-27
Start date
2002-10-15
Completion date
2013-09-19
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Brief summary

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.

Detailed description

OBJECTIVES: * Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation. * Compare progression-free survival of patients treated with these regimens. * Compare quality of life of patients treated with these regimens. * Compare toxic effects of these regimens in these patients. * Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens. OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation. For both arms, patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for up to 4 years, and then annually thereafter. After the treatment/observation period, patients are followed annually.. PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.

Interventions

DRUGprednisone

Given orally

DRUGthalidomide

Given orally

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Eastern Cooperative Oncology Group
CollaboratorNETWORK
NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma as evidenced by one of the following: * Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells * Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis * Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below * Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR * Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis * Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m\^2) within the past 60-100 days * Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma * No evidence of disease progression PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * No prior hereditary hypercoaguable disorder * Granulocyte count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and/or ALT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal * Creatinine no greater than 3 times ULN Cardiovascular * No prior spontaneous deep vein thrombosis within the past 5 years * Catheter-associated thrombus allowed * No uncontrolled hypertension Pulmonary * No prior pulmonary embolism within the past 5 years Other * No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more than 5 years prior to study entry and presumed cured * No prior gastric ulceration or bleeding within the past 5 years * No prior documented lupus anti-coagulant or anti-phospholipid antibody * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use 2 effective methods of contraception for 1 month prior, during, and 1 month after study participation * Male patients must use effective barrier contraception during and for 1 month after study participation * No avascular necrosis of the hips or shoulders * No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction (vincristine-induced sensory symptoms allowed) * No diabetes with end-organ damage defined as: * Documented diabetic neuropathy * Retinal vascular proliferation requiring treatment * Cardiovascular disease requiring active therapy * Willing to complete quality of life questionnaires * Employment does not prohibit the use of sedatives * No other major medical illness or condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior double autologous or allogeneic hematopoietic stem cell transplantation * No prior thalidomide Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent anti-cancer therapy * No other concurrent investigational therapy

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival9 yearsNumber of patients died from any cause during the study.

Secondary

MeasureTime frameDescription
Disease Progression-free Survival9 yearsNumber of patients with disease progression or death

Countries

Canada

Participant flow

Participants by arm

ArmCount
Prednisone
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. prednisone: Given orally thalidomide: Given orally
166
Observation
Patients undergo observation.
166
Total332

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNo receive treatment/lost to follow-up13

Baseline characteristics

CharacteristicPrednisoneObservationTotal
Age, Customized
Age < 60
102 Participants103 Participants205 Participants
Age, Customized
Age > or = 60
64 Participants63 Participants127 Participants
Region of Enrollment
Canada
162 participants162 participants324 participants
Region of Enrollment
United States
4 participants4 participants8 participants
Sex: Female, Male
Female
58 Participants56 Participants114 Participants
Sex: Female, Male
Male
108 Participants110 Participants218 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
50 / 16561 / 163
other
Total, other adverse events
165 / 165158 / 163
serious
Total, serious adverse events
5 / 1652 / 163

Outcome results

Primary

Overall Survival

Number of patients died from any cause during the study.

Time frame: 9 years

Population: Intention-to-treat population

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
PrednisoneOverall SurvivalDeath50 Participants
PrednisoneOverall SurvivalAlive116 Participants
ObservationOverall SurvivalDeath61 Participants
ObservationOverall SurvivalAlive105 Participants
p-value: 0.1895% CI: [0.53, 1.14]Log Rank
Secondary

Disease Progression-free Survival

Number of patients with disease progression or death

Time frame: 9 years

Population: Intention-to-treat

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
PrednisoneDisease Progression-free SurvivalDisease progression100 Participants
PrednisoneDisease Progression-free SurvivalWithout progression66 Participants
ObservationDisease Progression-free SurvivalDisease progression127 Participants
ObservationDisease Progression-free SurvivalWithout progression39 Participants
p-value: 0.000195% CI: [0.43, 0.73]Log Rank

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026