Multiple MyelomaPhase 2NCT02230917
A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma
A Phase 2 study testing Sotatercept in people with Multiple Myeloma, run by Rebecca Silbermann at 1 site in United States.
Trial summary
Lytic bone disease continues to be one of the most devastating complications of multiple myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions persist and can continue to significantly impact a patient's morbidity, even when an individual's myeloma is otherwise under good control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2016
- 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
- Age > 18 years at the time of signing the informed consent form.
- Documented diagnosis of Multiple Myeloma, currently with complete response (CR) or very good partial response (VGPR) (as defined by IMWG criteria), at least two years after induction therapy or autologous stem cell transplant.
- Patients must not be receiving anti-Myeloma therapy (including maintenance therapy).
- Disease response must be confirmed with repeat laboratory studies at least 30 days apart.
- Radiologic evidence of at least 1 measurable lytic lesion in the arm, pelvis or leg. Completion of two years monthly zoledronic acid therapy.
- Eastern Cooperative Group (ECOG) performance status 0- 2
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- Creatinine ≤1.5 x upper limit of normal (ULN) or ≥40 mL/min
- Total bilirubin ≤ 3.0 mg/dL (bilirubin ≤1.5 x upper limit normal)
- AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN and ≤ 5.0 ULN for subjects with liver metastases
- Hemoglobin ≥ 7.5 g/dL and ≤ 13 g/dL
- Absolute neutrophil count ≥1500/uL
- Platelet count ≥ 75,000/ uL (>72 hours since prior platelet transfusion)
- Corrected calcium within normal limits, previous hypercalcemia allowed
- Females of childbearing potential must use a highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of sotatercept.
- Males must use latex condom or non-latex condom not made of (animal) membrane during any sexual contact with female of childbearing potential while participating in the study and for at least 112 days following the last dose of sotatercept, even if he has undergone successful vasectomy.
Who cannot join
- History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke AND have not been stable on anticoagulants within the past 6 months. Local central line thrombosis is allowed.
- History of polycythemia
- Uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg.)
- History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
- Current use of anti-cancer cytotoxic chemotherapeutic agents.
- Major surgery within 30 days of Day 1 of trial.
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- Incomplete recovery or incomplete healing of wounds from previous surgery, as determined by treating Investigator.
- Subjects with classification of 3 or higher heart failure as classified by the New York Heart Association (NYHA). Please see Appendix IV.
- Women who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the period of treatment and for 112 days following the last dose of sotatercept.
- Treatment with another investigational drug or device within 28 days prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life of the investigational drug prior to dosing, whichever is longer.
- Prior exposure to sotatercept.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that, as determined by the treating Investigator, would prevent the subject from participating in the study or providing written informed consent.
- Any condition including the presence of laboratory abnormality that, as determined by the treating Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Known positive for human immunodeficiency virus (HIV)
- Known positive for infectious hepatitis type C or active infectious hepatitis type B.
- Any condition that, as determined by the treating Investigator, confounds the interpretation of data from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Lytic bone disease continues to be one of the most devastating complications of multiple myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions persist and can continue to significantly impact a patient's morbidity, even when an individual's myeloma is otherwise under good control. To date, no agent has been shown to have a prolonged bone anabolic response in myeloma.
Preliminary studies treating healthy postmenopausal women with a single dose of sotatercept demonstrated a rapid and sustained increase in serum biochemical markers of bone formation and a decrease in markers of bone resorption. Similarly, the murine analog to sotatercept, RAP-011, increases bone mineral density and strength in murine studies of both normal animals and models of bone loss. We hypothesize that sotatercept will provide an anabolic response for bone in myeloma patients with bone disease.
- Conditions
- Multiple Myeloma
- Being tested
- Sotatercept, Placebo
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptDrug
Also called ACE-011
PlaceboDrug
Also called Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept | Experimental | Sotatercept 0.2 mg/kg will be administered every 21 days for 12 doses subcutaneously into the upper arm, abdomen or thigh. Receives: Drug: Sotatercept |
| Placebo | Placebo comparator | 0.2 mg/kg of normal saline will be administered subcutaneously in the upper arm, abdomen or thigh for 21 days for 12 doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of biochemical bone turnover
The presence of change in biochemical markers of bone turnover during treatment with sotatercept will be examined.
Measured: Average of 3 months
Secondary outcomes (4)
Number of Adverse Events related to sotatercept
Measured: Average of 21 days
Bone marrow density
Change in bone mineral density of the femoral neck, forearm and spine.
Measured: Average of 12 months
Change in biochemical myeloma markers
The change in myeloma markers will be determined by quantifying immunoglobulins, SPEP, UPEP and free light chains.
Measured: Average of 3 months
Size of target bone lesions
Measure the change in size of target bone lesions using x-ray of target skeletal lesions.
Measured: Average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2016
- Study completionJun 2016
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Silbermann
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor-investigator, Rebecca Silbermann, Indiana University
- Investigators
- Rebecca Silbermann, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230917
- Sponsor's protocol ID
- IUCRO-0428
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2014
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02230917
- Acronym / sponsor ID
- IUCRO-0428
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rebecca SilbermannUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Sep 2014 (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.
Lytic bone disease continues to be one of the most devastating complications of multiple myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions persist and can continue to significantly impact a patient's morbidity, even when an individual's myeloma is otherwise under good control. To date, no agent has been shown to have a prolonged bone anabolic response in myeloma.
Preliminary studies treating healthy postmenopausal women with a single dose of sotatercept demonstrated a rapid and sustained increase in serum biochemical markers of bone formation and a decrease in markers of bone resorption. Similarly, the murine analog to sotatercept, RAP-011, increases bone mineral density and strength in murine studies of both normal animals and models of bone loss. We hypothesize that sotatercept will provide an anabolic response for bone in myeloma patients with bone disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotatercept | Experimental | Drug: SotaterceptSotatercept 0.2 mg/kg will be administered every 21 days for 12 doses subcutaneously into the upper arm, abdomen or thigh. |
| Placebo | Placebo comparator | Drug: Placebo0.2 mg/kg of normal saline will be administered subcutaneously in the upper arm, abdomen or thigh for 21 days for 12 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age > 18 years at the time of signing the informed consent form.
- Documented diagnosis of Multiple Myeloma, currently with complete response (CR) or very good partial response (VGPR) (as defined by IMWG criteria), at least two years after induction therapy or autologous stem cell transplant.
- Patients must not be receiving anti-Myeloma therapy (including maintenance therapy).
- Disease response must be confirmed with repeat laboratory studies at least 30 days apart.
- Radiologic evidence of at least 1 measurable lytic lesion in the arm, pelvis or leg. Completion of two years monthly zoledronic acid therapy.
Key exclusion criteria (16 listed)
- History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke AND have not been stable on anticoagulants within the past 6 months. Local central line thrombosis is allowed.
- History of polycythemia
- Uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg.)
- History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
- Current use of anti-cancer cytotoxic chemotherapeutic agents.
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 |
|---|---|---|
| SotaterceptAlso: ACE-011 | Drug | Sotatercept |
| PlaceboAlso: Normal Saline | Drug | Placebo |
Primary outcome
Presence of biochemical bone turnover
Time frame: Average of 3 months
The presence of change in biochemical markers of bone turnover during treatment with sotatercept will be examined.
4 secondary outcomes
Number of Adverse Events related to sotatercept
Time frame: Average of 21 days
Bone marrow density
Time frame: Average of 12 months
Change in biochemical myeloma markers
Time frame: Average of 3 months
Size of target bone lesions
Time frame: Average of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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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.
Rebecca Silbermann, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotatercept in people with Multiple Myeloma, run by Rebecca Silbermann at 1 site in United States.
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 15 inclusion and 16 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: withdrawn, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Presence of biochemical bone turnover (time frame: Average of 3 months). 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 1 Sep 2016.