NCT00259740 · REGISTRY CONDITION SEARCH

Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab

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: 2017-03-15

The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.

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 or Partial Response Based on M-Protein Assessments Only

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outcome · POSTED

Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only

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outcome · POSTED

Complete Response Based on M-Protein Assessments Only

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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: * age ≥ 18 years * clinical diagnosis of relapsed or plateau-phase multiple myeloma * measurable disease (\>0.5 g/dL) as determined by special blood tests * ECOG 0 or 1 Exclusion Criteria: * newly diagnosed myeloma * non-secretory myeloma * plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome * prior allogeneic stem cell transplant * administration of oral or IV bisphosphonates within 2 weeks of enrollment to study Other criteria also apply.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: DENOSUMAB
label
Denosumab
type
EXPERIMENTAL

interventions

arm Group Labels
Denosumab
description
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.
name
DENOSUMAB
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 96
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Complete Response or Partial Response Based on M-Protein Assessments Only
time Frame
Up to 18 months

secondary Outcomes

description
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.
measure
Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
time Frame
Up to 18 months
description
Complete response based on M-protein assessments, as defined for the primary outcome measure.
measure
Complete Response Based on M-Protein Assessments Only
time Frame
Up to 18 months

Full study description

brief Summary: The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
detailed Description: 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.

Source references

references

citation
Vij R, Horvath N, Spencer A, Taylor K, Vadhan-Raj S, Vescio R, Smith J, Qian Y, Yeh H, Jun S. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol. 2009 Oct;84(10):650-6. doi: 10.1002/ajh.21509.
pmid
19714603
type
BACKGROUND