A Phase 2 interventional study of DENOSUMAB in Relapsed or Plateau-Phase Multiple Myeloma, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-15.
Sponsored by Amgen · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are limited and may include best supportive care and investigational therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without further tumor regression despite continued treatment. Recent evidence suggests that their prognosis might improve with further reduction in serum M-protein or prolongation of time to disease progression (TTP). These patients are candidates for investigational agents that could further reduce tumor burden or increase TTP.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 96 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other criteria also apply.
Drug: DENOSUMAB
120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.
Complete Response or Partial Response Based on M-Protein Assessments Only
Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
Time frame: Up to 18 months
Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.
Time frame: Up to 18 months
Complete Response Based on M-Protein Assessments Only
Complete response based on M-protein assessments, as defined for the primary outcome measure.
Time frame: Up to 18 months
Participants were enrolled from 13 February 2006 through 8 December 2006
| Milestone | Denosumab 120 mg Q4W - Plateau-Phase | Denosumab 120 mg Q4W - Relapsed |
|---|---|---|
| Started | 43 | 53 |
| Received study medication | 42 | 53 |
| Completed | 0 | 0 |
| Not completed | 43 | 53 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Withdrawal by subject | 2 | 6 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Disease progression | 19 | 36 |
| Withdrew: Ongoing | 17 | 3 |
| Withdrew: Other | 3 | 0 |
| Withdrew: Requirement for alternative therapy | 0 | 4 |
Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
| Participants | Denosumab 120 mg Q4W - Plateau-Phase | Denosumab 120 mg Q4W - Relapsed |
|---|---|---|
| Complete Response or Partial Response Based on M-Protein Assessments Only | 0 | 0 |
Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.
| Participants | Denosumab 120 mg Q4W - Plateau-Phase | Denosumab 120 mg Q4W - Relapsed |
|---|---|---|
| Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only | 0 | 0 |
Complete response based on M-protein assessments, as defined for the primary outcome measure.
| Participants | Denosumab 120 mg Q4W - Plateau-Phase | Denosumab 120 mg Q4W - Relapsed |
|---|---|---|
| Complete Response Based on M-Protein Assessments Only | 0 | 0 |
Collected over up to 1 year 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Denosumab 120 mg Q4W - Relapsed | — | 14/53 (26.4%) | 38/53 (71.7%) |
| Denosumab 120 mg Q4W - Plateau-Phase | — | 6/42 (14.3%) | 32/42 (76.2%) |
| Event | Denosumab 120 mg Q4W - Relapsed | Denosumab 120 mg Q4W - Plateau-Phase |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/53 | 0/42 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/53 | 0/42 |
| Multiple myelomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/53 | 0/42 |
| Renal failureRenal and urinary disorders | 2/53 | 0/42 |
| Intestinal obstructionGastrointestinal disorders | 0/53 | 1/42 |
| Intestinal perforationGastrointestinal disorders | 0/53 | 1/42 |
| Haemophilus infectionInfections and infestations | 0/53 | 1/42 |
| PneumoniaInfections and infestations | 1/53 | 1/42 |
| Septic shockInfections and infestations | 0/53 | 1/42 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/53 | 1/42 |
| Event | Denosumab 120 mg Q4W - Relapsed | Denosumab 120 mg Q4W - Plateau-Phase |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 9/53 | 12/42 |
| FatigueGeneral disorders | 8/53 | 8/42 |
| HeadacheNervous system disorders | 4/53 | 8/42 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/53 | 7/42 |
| AnaemiaBlood and lymphatic system disorders | 8/53 | 3/42 |
| DiarrhoeaGastrointestinal disorders | 7/53 | 6/42 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 7/53 | 3/42 |
| Back painMusculoskeletal and connective tissue disorders | 7/53 | 4/42 |
| Oedema peripheralGeneral disorders | 0/53 | 5/42 |
| NauseaGastrointestinal disorders | 6/53 | 4/42 |
| Age, Continuous(Years) | Denosumab 120 mg Q4W - Plateau-Phase | Denosumab 120 mg Q4W - Relapsed | Total |
|---|---|---|---|
| Mean | 61.1 ± 11.4 | 62.9 ± 9.2 | 62.1 ± 10.2 |
| Sex: Female, Male(Participants) | Denosumab 120 mg Q4W - Plateau-Phase | Denosumab 120 mg Q4W - Relapsed | Total |
|---|---|---|---|
| Female | 26 | 13 | 39 |
| Male | 17 | 40 | 57 |
| Race/Ethnicity, Customized(Participants) | Denosumab 120 mg Q4W - Plateau-Phase | Denosumab 120 mg Q4W - Relapsed | Total |
|---|---|---|---|
| Caucasian | 35 | 39 | 74 |
| African American | 4 | 7 | 11 |
| Hispanic or Latino | 1 | 3 | 4 |
| Other | 3 | 4 | 7 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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