Smoldering Multiple MyelomaPhase 2NCT01302886
Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
A Phase 2 study testing BHQ880 in people with Smoldering Multiple Myeloma, run by Novartis Pharmaceuticals at 13 sites in 3 countries.
Trial summary
This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Multiple Myeloma
- What is being tested?
- BHQ880
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 13 sitesin 3 countries
- Study dates
- May 2011to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
- BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
- BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0
- No previous or current anti-myeloma therapies
- Patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1
Who cannot join
- Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
- Another primary malignant disease that requires systemic treatment
- Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
- Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
- Treatment with an investigational product within 28 days before the first dose of study treatment
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States10 sites
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
Atlanta, Georgia, 30322
Dana Farber Cancer Institute DFCI (2)
Boston, Massachusetts, 02115
Duke University Medical Center Duke SC
Durham, North Carolina, 27710
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, 72703
Hackensack University Medical Center Multiple Myeloma Division
Hackensack, New Jersey, 07601
Indiana University Indiana Univ
Indianapolis, Indiana, 46202
Mount Sinai School of Medicine Mt Sinai
New York, New York, 10029
Fred Hutchinson Cancer Research Center Fred Hutchinson
Seattle, Washington, 98109
Washington University School of Medicine Dept. of WUSTL
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center & Research Institute SC - 3
Tampa, Florida, 33612
Germany2 sites
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Würzburg, 97080
About this study
Official title: A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma
This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.
- Conditions
- Smoldering Multiple Myeloma
- Being tested
- BHQ880
- Keywords
- High risk Smoldering multiple myeloma,, BHQ880,, MM
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHQ880Drug
| Study group | Role | What they receive |
|---|---|---|
| BHQ880 | Experimental | Not described Receives: Drug: BHQ880 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A
Measured: at 6 month
Secondary outcomes (4)
Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values
Measured: From start of study until disease progression
Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma
Measured: Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
Measured: Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoldering Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302886
- Sponsor's protocol ID
- CBHQ880A2204
- Other IDs
- 2010-022029-13
- Status last verified
- Feb 2017
- First submitted
- 26 Jan 2011
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01302886
- Acronym / sponsor ID
- CBHQ880A2204
- Conditions
- Smoldering Multiple Myeloma
- Keywords
- High risk Smoldering multiple myeloma,, BHQ880,, MM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BHQ880 | Experimental | Drug: BHQ880 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
- No previous or current anti-myeloma therapies
- Patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1
Key exclusion criteria (8 listed)
- Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
- Another primary malignant disease that requires systemic treatment
- Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
- Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
- Treatment with an investigational product within 28 days before the first dose of study treatment
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 |
|---|---|---|
| BHQ880 | Drug | BHQ880 |
Primary outcome
Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A
Time frame: at 6 month
4 secondary outcomes
Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values
Time frame: From start of study until disease progression
Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma
Time frame: Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
Time frame: Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results for CBHQ880A2204 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BHQ880 in people with Smoldering Multiple Myeloma, run by Novartis Pharmaceuticals at 13 sites in 3 countries.
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 6 inclusion and 8 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A (time frame: at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.