Relapsed Multiple MyelomaPhase 1NCT01118689
Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
A Phase 1 study testing MLN0128 in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Waldenstrom Macroglobulinemia
- What is being tested?
- MLN0128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2010to Jul 2013
- 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
- Age ≥18 years, including males and females;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of ≥3 months;
- Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
- For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
- Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
- Ability to swallow oral medications;
- Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;
Who cannot join
- Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
- Known impaired cardiac function or clinically significant cardiac disease
- HIV infection;
- Failed to recover from the reversible effects of prior anticancer therapies:
- Pregnancy (positive serum or urine pregnancy test) or breast feeding;
- Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Boston, Massachusetts, 02115
Study site
Denver, Colorado, 80218
Study site
Hackensack, New Jersey, 07601
Study site
Nashville, Tennessee, 37203
Study site
San Francisco, California, 94143
Study site
St Louis, Missouri, 63110
About this study
Official title: A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
- Being tested
- MLN0128
- Medical subject headings
- Multiple Myeloma, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN0128Drug
MLN0128 administered orally once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| MLN0128 | Experimental | Not described Receives: Drug: MLN0128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the dose limiting toxicities
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118689
- Sponsor's protocol ID
- INK-128-002
- Status last verified
- Jul 2013
- First submitted
- 5 May 2010
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
- ClinicalTrials.gov ID
- NCT01118689
- Acronym / sponsor ID
- INK-128-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 May 2010 (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 purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MLN0128 | Experimental | Drug: MLN0128 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, including males and females;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of ≥3 months;
- Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
- For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
Key exclusion criteria (6 listed)
- Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
- Known impaired cardiac function or clinically significant cardiac disease
- HIV infection;
- Failed to recover from the reversible effects of prior anticancer therapies:
- Pregnancy (positive serum or urine pregnancy test) or breast feeding;
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 |
|---|---|---|
| MLN0128MLN0128 administered orally once daily for 28 days | Drug | MLN0128 |
Primary outcome
determine the dose limiting toxicities
Time frame: 28-days
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 2 Aug 2013.
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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.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
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 MLN0128 in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. 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 8 inclusion and 6 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 2 Aug 2013. 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?
determine the dose limiting toxicities (time frame: 28-days). 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 2 Aug 2013.