A Phase 3 interventional study of prednisone and thalidomide in Multiple Myeloma and Plasma Cell Neoplasm, sponsored by NCIC Clinical Trials Group. Completed at 18 sites in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by NCIC Clinical Trials Group · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
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.
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 332 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →NCIC Clinical Trials Group is the lead sponsor of 116 studies on the registry; none are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
confirmed multiple myeloma as evidenced by one of the following:
Previously treated with stem cell transplantation after high-dose melphalan (200 mg/m\^2) within the past 60-100 days
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Cardiovascular
No prior spontaneous deep vein thrombosis within the past 5 years
Pulmonary
Other
No diabetes with end-organ damage defined as:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
Drug: prednisone · Drug: thalidomide
Patients undergo observation.
Given orally
Given orally
Overall Survival
Number of patients died from any cause during the study.
Time frame: 9 years
Disease Progression-free Survival
Number of patients with disease progression or death
Time frame: 9 years
| Milestone | Prednisone | Observation |
|---|---|---|
| Started | 166 | 166 |
| Completed | 165 | 163 |
| Not completed | 1 | 3 |
| Withdrew: No receive treatment/lost to follow-up | 1 | 3 |
Number of patients died from any cause during the study.
| Participants | Prednisone | Observation |
|---|---|---|
| Death | 50 | 61 |
| Alive | 116 | 105 |
Number of patients with disease progression or death
| Participants | Prednisone | Observation |
|---|---|---|
| Disease progression | 100 | 127 |
| Without progression | 66 | 39 |
Collected over 9 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prednisone | 50/165 (30.3%) | 5/165 (3%) | 165/165 (100%) |
| Observation | 61/163 (37.4%) | 2/163 (1.2%) | 158/163 (96.9%) |
| Event | Prednisone | Observation |
|---|---|---|
| OtherImmune system disorders | 1/165 | 1/163 |
| Renal failureRenal and urinary disorders | 0/165 | 1/163 |
| Sinus bradycardiaCardiac disorders | 1/165 | 0/163 |
| ColitisGastrointestinal disorders | 1/165 | 0/163 |
| SyncopeNervous system disorders | 1/165 | 0/163 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/165 | 0/163 |
| Event | Prednisone | Observation |
|---|---|---|
| Neuropathy-sensoryNervous system disorders | 147/165 | 71/163 |
| Bone painMusculoskeletal and connective tissue disorders | 119/165 | 121/163 |
| FatigueGeneral disorders | 120/165 | 95/163 |
| Infection w/o neutropenInfections and infestations | 113/165 | 88/163 |
| ConstipationGastrointestinal disorders | 97/165 | 32/163 |
| MyalgiaMusculoskeletal and connective tissue disorders | 74/165 | 51/163 |
| EdemaCardiac disorders | 72/165 | 29/163 |
| DizzinessNervous system disorders | 70/165 | 15/163 |
| InsomniaPsychiatric disorders | 69/165 | 44/163 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 69/165 | 33/163 |
| Age, Customized(Participants) | Prednisone | Observation | Total |
|---|---|---|---|
| Age < 60 | 102 | 103 | 205 |
| Age > or = 60 | 64 | 63 | 127 |
| Sex: Female, Male(Participants) | Prednisone | Observation | Total |
|---|---|---|---|
| Female | 58 | 56 | 114 |
| Male | 108 | 110 | 218 |
| Region of Enrollment(participants) | Prednisone | Observation | Total |
|---|---|---|---|
| Canada | 162 | 162 | 324 |
| United States | 4 | 4 | 8 |
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Prednisone · Thalidomide