Relapsed or Plateau-Phase Multiple MyelomaPhase 2NCT00259740

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

A Phase 2 study testing DENOSUMAB in people with Relapsed or Plateau-Phase Multiple Myeloma, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed or Plateau-Phase Multiple Myeloma
What is being tested?: DENOSUMAB
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: No sites listed yet
Study dates: Nov 2005to Dec 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

About this study

Official title: An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma

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

Read the 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.

Conditions: Relapsed or Plateau-Phase Multiple Myeloma
Being tested: DENOSUMAB
Keywords: Multiple Myeloma, Relapsed, Plateau-Phase
Medical subject headings: Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DENOSUMABDrug
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.

Study groups in NCT00259740
Study group	Role	What they receive
Denosumab	Experimental	Not described Receives: Drug: DENOSUMAB

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 18 months

Secondary outcomes (2)

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.
Measured: 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.
Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Dec 2011

First posted1 Dec 2005 (estimated)
Study startNov 2005
Primary completionAug 2007
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Relapsed or Plateau-Phase Multiple MyelomaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00259740
Sponsor's protocol ID: 20050134
Status last verified: Feb 2017
First submitted: 29 Nov 2005
Last updated: 15 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19714603

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
ClinicalTrials.gov ID: NCT00259740
Acronym / sponsor ID: 20050134
Conditions: Relapsed or Plateau-Phase Multiple Myeloma
Keywords: Multiple Myeloma, Relapsed, Plateau-Phase
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Aug 2007 (actual)
Study completion: Dec 2011 (actual)
First posted: 1 Dec 2005 (estimated)
Results: Posted 6 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Denosumab	Experimental	Drug: DENOSUMAB

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DENOSUMAB120 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.	Drug	Denosumab

Primary outcome

Complete Response or Partial Response Based on M-Protein Assessments Only
Time frame: Up to 18 months
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.

2 secondary outcomes

Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
Time frame: Up to 18 months
Complete Response Based on M-Protein Assessments Only
Time frame: Up to 18 months

Results and safety

Results posted to the registry on 6 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Denosumab 120 mg Q4W - Plateau-Phase	43	0
Denosumab 120 mg Q4W - Relapsed	53	0

Primary outcome: Complete Response or Partial Response Based on M-Protein Assessments Only

Time frame: Up to 18 months. Number. Unit: Participants

Measure	Denosumab 120 mg Q4W - Plateau-Phase n = 41	Denosumab 120 mg Q4W - Relapsed n = 53
Value	0	0

Population analysed: All participants who completed the first cycle of treatment with denosumab

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 1 year 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Denosumab 120 mg Q4W - Relapsed	14 of 53 (26.4%)	38 of 53 (71.7%)	Not reported
Denosumab 120 mg Q4W - Plateau-Phase	6 of 42 (14.3%)	32 of 42 (76.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19714603Vij 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DENOSUMAB in people with Relapsed or Plateau-Phase Multiple Myeloma, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response or Partial Response Based on M-Protein Assessments Only (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00259740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.