Multiple MyelomaPhase 1/2NCT01695590
Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma
A Phase 1/2 study testing PRLX 93936 in people with Multiple Myeloma, run by Prolexys Pharmaceuticals at 6 sites in United States.
Trial summary
To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory 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?
- PRLX 93936
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2012to Sep 2014
- Phase
- Phase 1/2
- 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
- Patient must have a diagnosis of multiple myeloma and have relapsed or relapsed/refractory disease.
- Patient must have received ≥ 2 prior anti-myeloma regimens including a proteasome inhibitor and/or immunomodulatory agent.
- Patient currently requires systemic therapy.
- Patient has measurable disease.
- Age ≥ 18 years
- Karnofsky performance status ≥ 60%
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- ECOG performance 0, 1 or 2
- Life expectancy of at least three months
- Able to take acetaminophen
- Not pregnant
- Patient must have recovered from toxicities incurred as a result of any previous anti-myeloma therapy or recovered to baseline.
- Patients who received an autologous stem cell transplant must be ≥ 3 months post-transplant and all associated toxicities must have resolved to ≤ CTCAE Grade 1.
- QT intervals of QTc ≤ 500 msec
Who cannot join
- POEMS syndrome
- Plasma cell leukemia
- Primary amyloidosis
- Patient has smoldering multiple myeloma or monoclonal gammopathy of unknown significance (MGUS).
- Evidence of spinal cord compression or CNS complication unless controlled by appropriate therapy.
- Patient received chemotherapy or other anti-cancer therapy that may be active against multiple myeloma within 3 weeks prior to the first dose of PRLX 93936.
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- Patient received nitrosureas within 6 weeks prior to the first dose.
- Patient received corticosteroids within 2 weeks prior to the first dose.
- Patient received plasmapheresis within 4 weeks prior to the first dose.
- Patient had major surgery within 4 weeks prior to the first dose.
- Patient had an allogeneic stem cell transplant within 6 months before first dose of PRLX 93936 or has evidence of graft versus host disease.
- Patient is taking any therapy concomitantly that may be active against multiple myeloma.
- Patient is currently receiving medication(s) that are principally metabolized via the cytochrome P450 3A4 enzyme pathway.
- Use of any investigational agents within 28 days or 5 half-lives (whichever is shorter) of study treatment.
- Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC.
- Patient had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Abnormal LVEF (< LLN for the institution for a patient of that age) on echocardiogram
- Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to protocol.
- Patient had a malignancy other than multiple myeloma within 3 years before enrollment, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer.
- Patient's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1:
- Bilirubin > 1.5 times ULN
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase > 2.5 times ULN
- Uncontrolled hypercalcemia (defined as serum calcium > 14 mg/dL)
- Serum creatinine > 2.0 mg/dL or creatinine clearance of < 30 mL/min
- ANC < 1000 cells/mm3 or < 750 cells/mm3 due to >50% marrow involvement
- Platelet count < 50,000 cells/mm3
- Hemoglobin < 8.0 g/dL
- Patient is known to be human immunodeficiency virus (HIV)-positive.
- Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
- Patient has an active systemic infection requiring treatment or within 14 days before first dose of PRLX 93936.
- Pregnant or nursing women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 5 recruiting
- Withdrawn
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Amy Destefanis, 617-632-6752, amyl_destefanis@dfci.harvard.edu
Robert Schlossman, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Barbara Riff, 919-843-7046, barbara_riff@med.unc.edu
Katherine McKernan, 919-966-4432, katherine_mckernan@med.unc.edu
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Sue O'Gara, 513-604-3982, sue.ogara@uc.edu
John Morris, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Kimberly Oates, 919-668-6524, kimberly.bartlett@duke.edu
Cristina Gasparetto, MD
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Cindy Farley, 615-329-7237, cindy.farley@scresearch.net
Jesus G. Berdeja, MD
About this study
Official title: Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
Read the detailed description
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
- To establish the dose of PRLX 93936 recommended for future studies.
- To characterize potential toxicities of PRLX 93936.
- To assess the pharmacokinetic profile of PRLX 93936.
- To evaluate response to treatment, time to response (TTR) and duration of response.
- To evaluate time to progression (TTP).
- Conditions
- Multiple Myeloma
- Being tested
- PRLX 93936
- Keywords
- Myeloma, PRLX93936
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRLX 93936Drug
PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered
| Study group | Role | What they receive |
|---|---|---|
| PRLX 93936 | Experimental | PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle Receives: Drug: PRLX 93936 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: Cycle 1 (28 days from first dose)
Secondary outcomes (4)
Response to treatment
Measured: Each cycle (assessed every 28 days starting from first dose, for up to 8 months)
Time to response
Measured: From date of first dose to date of response, assessed up to 8 months
Duration of response
Measured: From date of response to first documented progression or death, or date last known progression-free and alive at study discontinuation, assessed up to 8 months
Time to progression
Measured: From date of first dose to first documented progression, assessed up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionSep 2014 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prolexys Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Richardson, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695590
- Sponsor's protocol ID
- PRLX93936-0002
- Status last verified
- May 2013
- First submitted
- 18 Sep 2012
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01695590
- Acronym / sponsor ID
- PRLX93936-0002
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, PRLX93936
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prolexys PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 28 Sep 2012 (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.
To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
Detailed description
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
- To establish the dose of PRLX 93936 recommended for future studies.
- To characterize potential toxicities of PRLX 93936.
- To assess the pharmacokinetic profile of PRLX 93936.
- To evaluate response to treatment, time to response (TTR) and duration of response.
- To evaluate time to progression (TTP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRLX 93936 | Experimental | Drug: PRLX 93936PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient must have a diagnosis of multiple myeloma and have relapsed or relapsed/refractory disease.
- Patient must have received ≥ 2 prior anti-myeloma regimens including a proteasome inhibitor and/or immunomodulatory agent.
- Patient currently requires systemic therapy.
- Patient has measurable disease.
- Age ≥ 18 years
Key exclusion criteria (31 listed)
- POEMS syndrome
- Plasma cell leukemia
- Primary amyloidosis
- Patient has smoldering multiple myeloma or monoclonal gammopathy of unknown significance (MGUS).
- Evidence of spinal cord compression or CNS complication unless controlled by appropriate therapy.
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 |
|---|---|---|
| PRLX 93936PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered | Drug | PRLX 93936 |
Primary outcome
Maximum Tolerated Dose
Time frame: Cycle 1 (28 days from first dose)
4 secondary outcomes
Response to treatment
Time frame: Each cycle (assessed every 28 days starting from first dose, for up to 8 months)
Time to response
Time frame: From date of first dose to date of response, assessed up to 8 months
Duration of response
Time frame: From date of response to first documented progression or death, or date last known progression-free and alive at study discontinuation, assessed up to 8 months
Time to progression
Time frame: From date of first dose to first documented progression, assessed up to 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
University of North Carolina at Chapel Hill
Chapel Hill, United States
Paul Richardson, MD principal investigator
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRLX 93936 in people with Multiple Myeloma, run by Prolexys Pharmaceuticals 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 13 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 4 Jun 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: Cycle 1 (28 days from first dose)). 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 4 Jun 2013.