Multiple MyelomaPhase 1NCT00689507
A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib
A Phase 1 study testing LY2127399 in people with Multiple Myeloma, run by Applied Molecular Evolution at 6 sites in United States.
Trial summary
H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in patients with refractory or relapsed MM. 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?
- LY2127399
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2008to May 2014
- Phase
- 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
- Have relapsed or refractory multiple myeloma treated with at least 1 prior regimen. Prior therapy with bortezomib is allowed if there has been no relapse or progression within 3 months of the last dose of bortezomib, and bortezomib is considered by the treating physician to be a reasonable therapy for the patient.
- Have measurable disease defined by one or more of the following:
- Monoclonal protein in the serum of ≥1 g/dL (10 g/L).
- Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours.
- Involved Serum Free Light Chain (SFLC) level > 10 mg/dL (100 mg/L) provided SFLC ratio is abnormal.
- Measurable plasmacytoma.
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- Are ≥ 18 years of age.
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function including:
- Absolute neutrophil count (ANC) ≥ 1000/microliter
- Platelet (PLT) count ≥ 50,000/microliter
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (if total is elevated check direct and, if normal, patient is eligible)
- Aspartate transaminase (AST) ≤ 3 x ULN
- Creatinine ≤ 3.0 mg/dl.
- Have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale (refer to Attachment JDCF.5).
- Have discontinued all previous therapies for cancer, including chemotherapy and radiotherapy at least 2 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 4 months following the last dose of study drug.
- Females with child bearing potential must have had a negative urine or serum pregnancy test ≤ 3 days prior to the first dose of study drug.
- Have an estimated life expectancy of ≥ 16 weeks.
- Treatment with prior autologous transplant is permitted. If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered one line of treatment with the preceding chemotherapy.
Who cannot join
- Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
- Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
- Have uncontrolled infection.
- Females who are pregnant or lactating.
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
- Have peripheral neuropathy of > Grade 2, or of any grade with pain, as measured by CTCAE v3.0.
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- Previously treated with LY2127399, or have had significant allergy to humanized monoclonal antibodies that, in the opinion of the investigator, poses an increased risk to the patient.
- Prior allogeneic hematopoietic stem cell transplant.
- Prior therapy with experimental agents targeting BAFF.
- Have QTc interval > 450 msec on baseline 12-lead ECG.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama
Birmingham, Alabama, 35294-3300
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
UCLA
Los Angeles, California, 90024
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in patients with refractory or relapsed MM.
Read the detailed description
This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the safety of LY2127399 in combination with bortezomib and any side effects that might be associated with it; (2)Assess whether LY2127399 in combination with bortezomib may help patients with relapsed or refractory multiple myeloma; (3)How much LY2127399 should be given to patients along with bortezomib.
- Conditions
- Multiple Myeloma
- Being tested
- LY2127399
- Keywords
- Multiple Myeloma, Relapsed, Refractory, Bortezomib, Velcade
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2127399Biological
monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase(Part A): | Experimental | 1,10, 30, 100 or 300 mg of LY2127399 IV on day 1 of specific 21 day cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each 21 day cycle Receives: Biological: LY2127399 |
| Dose Confirmation Phase (Part B1): | Experimental | Dose determined by PK/PD modeling, LY2127399 IV on day 2 of Cycle 1 and on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each cycle Receives: Biological: LY2127399 |
| Dose Confirmation Phase (Part B2): | Experimental | Dose determined by PK/PD modeling, LY2127399 IV on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of specific cycles Receives: Biological: LY2127399 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose
Measured: 2 years
Secondary outcomes (3)
Safety and toxicity profile for LY2127399 in combination with bortezomib
Measured: 2 years
Response rate, duration of response, and time to progression of LY2127399 in combination with bortezomib
Measured: 2 years
Response rate, duration of response, and time to progression of LY2127399 as a single-agent
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2013
- Study completionMay 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Molecular Evolution
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Susan Carpenter, PhD, Study director, Applied Molecular Evolution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689507
- Sponsor's protocol ID
- H9S-MC-JDCF
- Status last verified
- May 2015
- First submitted
- 29 May 2008
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00689507
- Acronym / sponsor ID
- H9S-MC-JDCF
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Relapsed, Refractory, Bortezomib, Velcade
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Applied Molecular EvolutionIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Mar 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Jun 2008 (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.
H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in patients with refractory or relapsed MM.
Detailed description
This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the safety of LY2127399 in combination with bortezomib and any side effects that might be associated with it; (2)Assess whether LY2127399 in combination with bortezomib may help patients with relapsed or refractory multiple myeloma; (3)How much LY2127399 should be given to patients along with bortezomib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase(Part A): | Experimental | Biological: LY21273991,10, 30, 100 or 300 mg of LY2127399 IV on day 1 of specific 21 day cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each 21 day cycle |
| Dose Confirmation Phase (Part B1): | Experimental | Biological: LY2127399Dose determined by PK/PD modeling, LY2127399 IV on day 2 of Cycle 1 and on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each cycle |
| Dose Confirmation Phase (Part B2): | Experimental | Biological: LY2127399Dose determined by PK/PD modeling, LY2127399 IV on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of specific cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Have relapsed or refractory multiple myeloma treated with at least 1 prior regimen. Prior therapy with bortezomib is allowed if there has been no relapse or progression within 3 months of the last dose of bortezomib, and bortezomib is considered by the treating physician to be a reasonable therapy for the patient.
- Have measurable disease defined by one or more of the following:
- Are ≥ 18 years of age.
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function including:
Key exclusion criteria (10 listed)
- Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
- Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
- Have uncontrolled infection.
- Females who are pregnant or lactating.
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
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 |
|---|---|---|
| LY2127399monoclonal antibody | Biological | Dose Confirmation Phase (Part B1):, Dose Confirmation Phase (Part B2):, Dose Escalation Phase(Part A): |
Primary outcome
Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose
Time frame: 2 years
3 secondary outcomes
Safety and toxicity profile for LY2127399 in combination with bortezomib
Time frame: 2 years
Response rate, duration of response, and time to progression of LY2127399 in combination with bortezomib
Time frame: 2 years
Response rate, duration of response, and time to progression of LY2127399 as a single-agent
Time frame: 2 years
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 29 Jun 2015.
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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.
Susan Carpenter, PhD study director
Applied Molecular Evolution
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2127399 in people with Multiple Myeloma, run by Applied Molecular Evolution at 6 sites 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 22 inclusion and 10 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 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose (time frame: 2 years). 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 29 Jun 2015.