Multiple MyelomaPhase 1NCT00388999
Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
A Phase 1 study testing Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) in people with Multiple Myeloma, run by Enzon Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
MBL deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhMBL. 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?
- Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2009
- 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
None listed.
Who cannot join
- Concurrent serious medical illness that could potentially interfere with protocol compliance.
- Concurrent or previous malignancy associated with a poor prognosis.
- Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS) or hepatitis (for hepatitis and human immunodeficiency virus [HIV] will not be performed).
- Positive screening pregnancy test or is breast-feeding.
- Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
- Known or clinically suspected active brain metastases.
- Current participation in another clinical study with an investigational agent and/or use of an investigational drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Multi-Center,Open-Label,Randomized,Phase 1B Study Evaluating Safety & Tolerability of Intravenous rhMBL in Pts With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant
MBL deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhMBL.
Read the detailed description
MBL deficient patients will be randomized in a ratio of 2:2:1 to receive up to 4 weekly i.v. infusions of rhMBL at a dose of 0.5 mg/kg or 1.0 mg/kg, or standard anti-infectious prophylactic therapy alone. A total of 20 patients will be treated in each of the rhMBL arms, and 10 patients will receive best standard supportive prophylactic therapy but not rhMBL. All patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards.
- Conditions
- Multiple Myeloma
- Being tested
- Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
- Keywords
- Multiple Myeloma, Stem Cell Transplant, rhMBL
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)Drug
Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)Drug
Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)Drug
Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
| Study group | Role | What they receive |
|---|---|---|
| 0 mg/kg | Other | Not described Receives: Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) |
| 0.5 mg/kg | Other | Not described Receives: Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) |
| 1.0 mg/kg | Other | Not described Receives: Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of rhMBL
Measured: 2 months
Secondary outcomes (3)
Pharmacokinetic (PK) of rhMBL
Measured: 2 months
Pharmacodynamics (PD) of rhMBL
Measured: 2 months
Immunogenicity of rhMBL, incidence of infectious complications
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionMay 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elias Anaissie, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388999
- Sponsor's protocol ID
- EZN-2232-01
- Status last verified
- Dec 2011
- First submitted
- 13 Oct 2006
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center,Open-Label,Randomized,Phase 1B Study Evaluating Safety & Tolerability of Intravenous rhMBL in Pts With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00388999
- Acronym / sponsor ID
- EZN-2232-01
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Stem Cell Transplant, rhMBL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Enzon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Oct 2006 (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.
MBL deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhMBL.
Detailed description
MBL deficient patients will be randomized in a ratio of 2:2:1 to receive up to 4 weekly i.v. infusions of rhMBL at a dose of 0.5 mg/kg or 1.0 mg/kg, or standard anti-infectious prophylactic therapy alone. A total of 20 patients will be treated in each of the rhMBL arms, and 10 patients will receive best standard supportive prophylactic therapy but not rhMBL. All patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0 mg/kg | Other | Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) |
| 0.5 mg/kg | Other | Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) |
| 1.0 mg/kg | Other | Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Concurrent serious medical illness that could potentially interfere with protocol compliance.
- Concurrent or previous malignancy associated with a poor prognosis.
- Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS) or hepatitis (for hepatitis and human immunodeficiency virus [HIV] will not be performed).
- Positive screening pregnancy test or is breast-feeding.
- Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
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 |
|---|---|---|
| Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg | Drug | 0 mg/kg |
| Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg | Drug | 0.5 mg/kg |
| Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg | Drug | 1.0 mg/kg |
Primary outcome
Safety and tolerability of rhMBL
Time frame: 2 months
3 secondary outcomes
Pharmacokinetic (PK) of rhMBL
Time frame: 2 months
Pharmacodynamics (PD) of rhMBL
Time frame: 2 months
Immunogenicity of rhMBL, incidence of infectious complications
Time frame: 2 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 5 Dec 2011.
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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.
Elias Anaissie, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) in people with Multiple Myeloma, run by Enzon Pharmaceuticals, Inc. 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 0 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 5 Dec 2011. 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?
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?
Safety and tolerability of rhMBL (time frame: 2 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 5 Dec 2011.