Multiple MyelomaEarly Phase 1NCT03173430
Pilot Study of Blinatumomab in Combination With Salvage Autologous Stem Cell Transplantation for Patients With Refractory Multiple Myeloma
A Early Phase 1 study testing Blinatumomab in people with Multiple Myeloma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This study involves receiving blinatumomab after high-dose melphalan and ASCT for multiple myeloma. The main purpose of this study is to: - To determine whether blinatumomab is safe and feasible to administer after ASCT in patients with advanced multiple myeloma. 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?
- Blinatumomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2017to 28 Jan 2019
- Phase
- Early Phase 1
- 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
- Subjects must have undergone a prior ASCT for multiple myeloma and have progressed within 365 days of stem cell infusion. Progression is defined according to IMWG criteria49.
- Prior ASCT must have utilized melphalan conditioning at a dose of 200 mg/m2.
- Patients who underwent syngeneic transplant (i.e., transplant from an identical twin donor) rather than autologous transplant are eligible if syngeneic stem cells are available for use in the salvage transplant and syngeneic transplant will be considered equivalent to ASCT for the purposes of these inclusion/exclusion criteria.
- Patients in whom first progression is identified between days 366 and 450 (inclusive) after ASCT will be eligible if progression is identified on their first evaluation for progression in this window and if they had not been evaluated between days 270 and 365 for progression. This clause is to account for practice patterns in which patients otherwise doing well are monitored infrequently (every 3-6 months) for relapse after they recover from their first ASCT. This will allow infrequently monitored patients to be included if progression is identified on their "12 month follow-up evaluation" if this appointment happens to be scheduled just outside the 365-day post-ASCT window.
- There is no requirement that patients must enroll within 365 days of prior ASCT, and patients may be treated with other agents, including experimental agents, following relapse/progression after prior ASCT before enrollment on this study.
- Subjects must have received as part of their initial therapy for multiple myeloma, prior to first ASCT, a regimen containing either bortezomib or lenalidomide.
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- Subjects must have signed written, informed consent.
- Subjects must be ≥ 18 and ≤ 70 years of age.
- Subjects must have adequate vital organ function to undertake ASCT, defined as the following:
- Estimated or measured creatinine clearance of ≥60 mL/min. CKD-EPI equation will be used for estimation of creatinine clearance (http://www.kidney.org/professionals/kdoqi/gfr_calculator).
- SGOT ≤ 3x the upper limit of normal and total bilirubin ≤ 2.0 mg/dl (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome).
- Left ventricular ejection fraction ≥45% as measured by echocardiography or MUGA scan.
- Adequate pulmonary function with FEV1, FVC, TLC, and DLCO (after appropriate adjustment for lung volume and hemoglobin concentration) ≥40% of predicted values.
- Non-hematologic toxicities from prior therapies must have recovered to grade ≤2 according to CTCAE 4.0 criteria or the subject's prior baseline.
- Subjects must have measurable disease, as defined in the IMWG response criteria49, on study entry.
- Subjects must have an ECOG performance status of 0-2 unless a higher performance status is due solely to bone pain.
- Subjects must have stored in usable condition for second ASCT, as judged by the principal investigator, ≥3x106 CD34+ cells per kg of body weight (either autologous or syngeneic) stored in at least two bags such that after administration of the minimum dose of 2 x 106 CD34+ cells/kg required on this protocol that a separate aliquot of at least 1 x 106 CD34+ cells/kg remains for rescue infusion in the event of graft failure.
- Subjects must agree not to attempt to become pregnant or impregnate others (e.g., through sexual intercourse or sperm donation) between enrollment and completion of blinatumomab therapy. Sexually active subjects with reproductive potential must agree during the study to utilize a reliable method of contraception, which may include condoms (male or female), diaphragm or cervical cap with spermicide, intrauterine device, or hormonal contraceptive. Acceptable documentation of the absence of reproductive potential may consist of any one of the following: (1) physician report/letter, (2) operative report or other source documentation of surgical sterilization, (3) laboratory report of azospermia (required to document successful vasectomy), (4) follicle stimulating hormone measurement elevated in the menopausal range.
- Due to the potential for neurological events, including seizures, while receiving blinatumomab, subjects must be willing and able to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery during the periods of blinatumomab infusion.
Who cannot join
- Pregnant or lactating. Female subjects of reproductive potential (women who have reached menarche and who have had menses within the preceding 24 months or have not undergone hysterectomy or bilateral oophorectomy) must have a negative serum pregnancy test performed at the time of screening.
- Active and uncontrolled infection
- Positive serum testing for hepatitis B core antibody or hepatitis B surface antigen.
- Evidence of active hepatitis C or HIV infection (positive serology with appropriate positive confirmatory testing, such as nucleic acid-based testing).
- Any condition that would preclude participation as outlined in the judgment of the principal investigator.
- Prior allogeneic stem cell transplantation.
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- Prior receipt of >1 autologous stem cell transplantation.
- Clinically significant CNS pathology, including documented or suspected CNS myeloma. Clinically insignificant clinical examination findings or imaging abnormalities (e.g., age-related changes) should not be cause for exclusions of potential subjects.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study involves receiving blinatumomab after high-dose melphalan and ASCT for multiple myeloma. The main purpose of this study is to: - To determine whether blinatumomab is safe and feasible to administer after ASCT in patients with advanced multiple myeloma. - To assess how long multiple myeloma remains under control when blinatumomab is administered after second ASCT.
- Conditions
- Multiple Myeloma
- Being tested
- Blinatumomab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Blinatumomab (Blincyto), an anti-CD19/anti-CD3 bi-specific T cell engager
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | An evaluable subject is any subject who completes two 28-day cycles of blinatumomab or discontinues blinatumomab after completion of less than one cycle due to toxicity. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start27 May 2017
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Why it stopped: PI decided to close study due to slow accrual.
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 Abramson Cancer Center at Penn MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred Garfall, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173430
- Sponsor's protocol ID
- UPCC 56416
- Status last verified
- Feb 2020
- First submitted
- 30 May 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Blinatumomab in Combination With Salvage Autologous Stem Cell Transplantation for Patients With Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03173430
- Acronym / sponsor ID
- UPCC 56416
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decided to close study due to slow accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 27 May 2017 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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 involves receiving blinatumomab after high-dose melphalan and ASCT for multiple myeloma. The main purpose of this study is to: - To determine whether blinatumomab is safe and feasible to administer after ASCT in patients with advanced multiple myeloma. - To assess how long multiple myeloma remains under control when blinatumomab is administered after second ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BlinatumomabAn evaluable subject is any subject who completes two 28-day cycles of blinatumomab or discontinues blinatumomab after completion of less than one cycle due to toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects must have undergone a prior ASCT for multiple myeloma and have progressed within 365 days of stem cell infusion. Progression is defined according to IMWG criteria49.
- Subjects must have signed written, informed consent.
- Subjects must be ≥ 18 and ≤ 70 years of age.
- Subjects must have adequate vital organ function to undertake ASCT, defined as the following:
- Subjects must have measurable disease, as defined in the IMWG response criteria49, on study entry.
Key exclusion criteria (9 listed)
- Pregnant or lactating. Female subjects of reproductive potential (women who have reached menarche and who have had menses within the preceding 24 months or have not undergone hysterectomy or bilateral oophorectomy) must have a negative serum pregnancy test performed at the time of screening.
- Active and uncontrolled infection
- Positive serum testing for hepatitis B core antibody or hepatitis B surface antigen.
- Evidence of active hepatitis C or HIV infection (positive serology with appropriate positive confirmatory testing, such as nucleic acid-based testing).
- Any condition that would preclude participation as outlined in the judgment of the principal investigator.
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 |
|---|---|---|
| BlinatumomabBlinatumomab (Blincyto), an anti-CD19/anti-CD3 bi-specific T cell engager | Drug | Arm 1 |
Primary outcome
Number of Adverse Events
Time frame: 18 months
Results and safety
The study was stopped early (reason given: PI decided to close study due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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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.
Alfred Garfall, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Blinatumomab in people with Multiple Myeloma, run by Abramson Cancer Center at Penn Medicine 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 19 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Feb 2020. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 stopped early (reason given: PI decided to close study due to slow accrual.). Results are not available in the source record.
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?
Number of Adverse Events (time frame: 18 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 7 Feb 2020.