Multiple MyelomaPhase 2NCT01337752
Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency
A Phase 2 study testing BHQ880, bortezomib and dexamethasone in people with Multiple Myeloma and Renal Insufficiency, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
Trial summary
The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Multiple Myeloma, Renal Insufficiency
- What is being tested?
- BHQ880, bortezomib and dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jan 2012to May 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of multiple myeloma
- Life expectancy of more than 6 months in the absence of intervention
- Must not have received previous or be receiving current antimyeloma therapies
- Renal insufficiency
- Recovered from the effects of any prior surgery or radiotherapy
Who cannot join
- Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
- Paget's disease of bone or uncorrected hyperparathyroidism
- Impaired cardiac function
- Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
- Pregnant or nursing (lactating) women,
- Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United Kingdom4 sites
Novartis Investigative Site
Bournemouth, BH7 7DW
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Oxford, OX3 7LJ
Novartis Investigative Site
Southampton, SO16 6YD
United States2 sites
University Chicago Hospital Dept. of Univ of Chicago (2)
Chicago, Illinois, 60637
Medical Oncology Associates, PS
Spokane, Washington, 99208
Spain2 sites
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Valencia, Valencia, 46026
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency
The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.
- Conditions
- Multiple Myeloma, Renal Insufficiency
- Being tested
- BHQ880, BHQ880 Placebo, bortezomib, dexamethasone
- Keywords
- multiple myeloma, renal insufficiency, untreated multiple myeloma
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHQ880Drug
BHQ880 PlaceboDrug
Intravenous infusion
bortezomibDrug
intravenous injection
dexamethasoneDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| BHQ880 + bortezomib and dexamethasone | Experimental | Not described Receives: Drug: BHQ880; Drug: bortezomib; Drug: dexamethasone |
| BHQ880 Placebo + bortezomib and dexamethasone | Placebo comparator | Not described Receives: Drug: BHQ880 Placebo; Drug: bortezomib; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone
Time to first SRE from randomization
Measured: 18-month median time to first SRE assumed for the placebo arm
Secondary outcomes (4)
safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone
Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity
Measured: From screening through month 17
Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib
Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880).
Measured: At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
Evaluate the effect of BHQ880 on bone metabolism
- Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA), from randomization to 12 and 18 months; 2) Change in bone strength, measured by quantitative computed tomography (qCT), from randomization to 3 and 6 months
Measured: At screening and at months 3, 6, 12, and 18
Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.
- The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880
Measured: From the first dose of study medication through month 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 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
- NCT01337752
- Sponsor's protocol ID
- CBHQ880A2203
- Other IDs
- 2009-010875-26, 2009
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 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 Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency
- ClinicalTrials.gov ID
- NCT01337752
- Acronym / sponsor ID
- CBHQ880A2203
- Conditions
- Multiple Myeloma, Renal Insufficiency
- Keywords
- multiple myeloma, renal insufficiency, untreated multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Apr 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.
The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHQ880 + bortezomib and dexamethasone | Experimental | Drug: BHQ880, Drug: bortezomib, Drug: dexamethasone |
| BHQ880 Placebo + bortezomib and dexamethasone | Placebo comparator | Drug: BHQ880 Placebo, Drug: bortezomib, Drug: dexamethasone |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of multiple myeloma
- Life expectancy of more than 6 months in the absence of intervention
- Must not have received previous or be receiving current antimyeloma therapies
- Renal insufficiency
- Recovered from the effects of any prior surgery or radiotherapy
Key exclusion criteria (7 listed)
- Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
- Paget's disease of bone or uncorrected hyperparathyroidism
- Impaired cardiac function
- Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
- Pregnant or nursing (lactating) women,
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 + bortezomib and dexamethasone |
| BHQ880 PlaceboIntravenous infusion | Drug | BHQ880 Placebo + bortezomib and dexamethasone |
| bortezomibintravenous injection | Drug | BHQ880 + bortezomib and dexamethasone, BHQ880 Placebo + bortezomib and dexamethasone |
| dexamethasoneOral | Drug | BHQ880 + bortezomib and dexamethasone, BHQ880 Placebo + bortezomib and dexamethasone |
Primary outcome
effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone
Time frame: 18-month median time to first SRE assumed for the placebo arm
Time to first SRE from randomization
4 secondary outcomes
safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone
Time frame: From screening through month 17
Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib
Time frame: At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
Evaluate the effect of BHQ880 on bone metabolism
Time frame: At screening and at months 3, 6, 12, and 18
Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.
Time frame: From the first dose of study medication through month 17
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 CBHQ880A2203 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
8 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, bortezomib and dexamethasone in people with Multiple Myeloma and Renal Insufficiency, run by Novartis Pharmaceuticals at 8 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 5 inclusion and 7 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 8 sites in United Kingdom, United States, Spain. 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. Some participants in this study may receive a placebo. 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?
effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone (time frame: 18-month median time to first SRE assumed for the placebo arm). 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.