Multiple MyelomaPhase 1NCT03288480
A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing PT-112 in people with Multiple Myeloma, run by Promontory Therapeutics Inc. at 7 sites in United States.
Trial summary
Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma. This is designed as a two-part study. 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?
- PT-112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Dec 2017to 1 Mar 2021
- 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
- Previously diagnosed with MM requiring treatment based on IMWG diagnostic criteria;
- Relapsed or refractory MM after adequate exposure to and therapeutic response (following IMWG response criteria) to at least one line of treatment with one or more active agents, including alkylating drugs, corticosteroids, immunomodulatory drugs (IMiD: thalidomide, lenalidomide, pomalidomide), proteasome inhibitors (bortezomib, cartilzomib), and monoclonal antibodies (daratumumab, elotuzumab, ixazomab);
- Evaluable MM with at least one of the following: (a) serum monoclonal component ≥ 0.5 g/dL; or (b) Bence Jones (BJ) proteinuria ≥ 200 mg/24h; or (c) measurable plasmacytoma (not previously irradiated); or (d) involved serum free light chain ≥ 10 mg/dL with an abnormal free light chain ratio;
- ECOG Performance Status (PS) 0-2;
- Life expectancy > 3 months;
- At least 2 weeks (or 5 half-lives, whichever is longer) wash-out since the end of previously administered experimental therapy (6 weeks if previous nitrosourea containing regimen) or 2 weeks for standard-of-care regimens. Concurrent corticosteroids are allowed provided they are administered at an equivalent prednisone dose of ≤ 10 mg/day, as prediction or blood products only;
- Recovery from non-hematologic toxic effects of prior therapy to grade ≤ 1 (except alopecia) by NCI CTCAE Version 4.03;
- Adequate bone marrow (BM), renal, hepatic and metabolic function.
Who cannot join
- Any of the following concomitant diseases/conditions:
- History or presence of myocardial infarction, clinically relevant valvular heart disease, or congestive heart failure within the last 12 months;
- Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to >480 msec for males or >500 msec for females, based on ECG at screening (patients with stable atrial fibrillation on treatment are allowed provided they do not meet any other cardiac or prohibited drug exclusion criterion);
- Presence of current angina;
- Active uncontrolled infection;
- Morphological or cytological features of myelodysplasia and/or post-chemotherapy aplasia on BM assessment;
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- Myopathy > grade 2 or any clinical situation that causes significant and persistent elevation of CPK (>2.5 x ULN in two different determinations performed one week apart);
- Peripheral neuropathy > grade 1, except for grade 2 without limitations on instrumental daily life activities;
- POEMS syndrome or active plasma cell leukemia;
- Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD;
- History or presence within the last 3 months of Deep Vein Thrombosis (DVT) or a pulmonary embolism (PE);- Uncontrolled leptomeningeal disease;
- Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia);
- Acute or chronic infections requiring systemic therapy, including, among others:
- active infection requiring systemic therapy;
- history of testing positive to human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;
- hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
- active tuberculosis (history of exposure or history of positive TB test with presence of clinical symptoms, physical or radiographic finding);
- Any other major illness that, in the Investigator's judgment, may substantially increase the risk associated with the patient's participation in this study;
- History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval;
- Prior irradiation to > 30% of BM reserves (including total body irradiation), regardless of the washout period;
- High dose chemotherapy followed by autologous stem cell transplantation within 90 days prior to initiating study treatment;
- Bisphosphonate treatment within 7 days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days 18 to 21 of the 28-day treatment cycle)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rocky Mountain Cancer Centers
Denver, Colorado, 80220
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240
About this study
Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma.
This is designed as a two-part study. In the first part of the study, cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of PT-112 until the MTD is reached, based on tolerability observed during the first 28 days of treatment. In the second part of the study, an expansion cohort of 14 patients will be treated at the recommended dose to confirm the tolerability of treatment and evaluate evidence of treatment efficacy.
- Conditions
- Multiple Myeloma
- Being tested
- PT-112
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-112Drug
This is a single arm study
| Study group | Role | What they receive |
|---|---|---|
| PT-112 | Other | This is a single arm study of PT-112, which is administered to patients with relapsed or refractory MM Receives: Drug: PT-112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose (RD) of PT-112 for further studies in patients with relapsed or refractory multiple myeloma (MM)
Measured: 18 months
Secondary outcomes (8)
Peak Plasma Concentration (Cmax)
Measured: 18 months
Area under the plasma concentration versus time curve (AUC)
Measured: 18 months
Dose-limiting toxicities (DLTs)
Measured: 18 months
Number of patients with Adverse Events (AEs)
Characterization of the type, incidence, severity, duration, reversibility and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.
Measured: 18 months
Tumor response, including assessment of minimal residual disease, according to the International Myeloma Working Group (IMWG) response criteria
Measured: 18 months
Duration of response
Measured: 18 months
Progression free survival
Measured: 18 months
Relationship between sensitivity/response to treatment and disease status including cytogenetic biomarkers
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 posted20 Sep 2017
- Study start15 Dec 2017
- Primary completion30 Sep 2020
- Study completion1 Mar 2021
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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-center, open-label study of PT-112 in patients with relapsed or refractory MM.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promontory Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leif Bergsagel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288480
- Sponsor's protocol ID
- PT-112-102
- Status last verified
- Apr 2022
- First submitted
- 11 Sep 2017
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03288480
- Acronym / sponsor ID
- PT-112-102
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Promontory Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 20 Sep 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.
Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma.
This is designed as a two-part study. In the first part of the study, cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of PT-112 until the MTD is reached, based on tolerability observed during the first 28 days of treatment. In the second part of the study, an expansion cohort of 14 patients will be treated at the recommended dose to confirm the tolerability of treatment and evaluate evidence of treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-center, open-label study of PT-112 in patients with relapsed or refractory MM.
| Arm | Type | Receives |
|---|---|---|
| PT-112 | Other | Drug: PT-112This is a single arm study of PT-112, which is administered to patients with relapsed or refractory MM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Previously diagnosed with MM requiring treatment based on IMWG diagnostic criteria;
- Relapsed or refractory MM after adequate exposure to and therapeutic response (following IMWG response criteria) to at least one line of treatment with one or more active agents, including alkylating drugs, corticosteroids, immunomodulatory drugs (IMiD: thalidomide, lenalidomide, pomalidomide), proteasome inhibitors (bortezomib, cartilzomib), and monoclonal antibodies (daratumumab, elotuzumab, ixazomab);
- Evaluable MM with at least one of the following: (a) serum monoclonal component ≥ 0.5 g/dL; or (b) Bence Jones (BJ) proteinuria ≥ 200 mg/24h; or (c) measurable plasmacytoma (not previously irradiated); or (d) involved serum free light chain ≥ 10 mg/dL with an abnormal free light chain ratio;
- ECOG Performance Status (PS) 0-2;
- Life expectancy > 3 months;
Key exclusion criteria (22 listed)
- Any of the following concomitant diseases/conditions:
- History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval;
- Prior irradiation to > 30% of BM reserves (including total body irradiation), regardless of the washout period;
- High dose chemotherapy followed by autologous stem cell transplantation within 90 days prior to initiating study treatment;
- Bisphosphonate treatment within 7 days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days 18 to 21 of the 28-day treatment cycle)
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 |
|---|---|---|
| PT-112This is a single arm study | Drug | PT-112 |
Primary outcome
Recommended dose (RD) of PT-112 for further studies in patients with relapsed or refractory multiple myeloma (MM)
Time frame: 18 months
8 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 18 months
Area under the plasma concentration versus time curve (AUC)
Time frame: 18 months
Dose-limiting toxicities (DLTs)
Time frame: 18 months
Number of patients with Adverse Events (AEs)
Time frame: 18 months
Tumor response, including assessment of minimal residual disease, according to the International Myeloma Working Group (IMWG) response criteria
Time frame: 18 months
Duration of response
Time frame: 18 months
Progression free survival
Time frame: 18 months
Relationship between sensitivity/response to treatment and disease status including cytogenetic biomarkers
Time frame: 18 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 26 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Leif Bergsagel, MD principal investigator
Mayo Clinic
7 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 PT-112 in people with Multiple Myeloma, run by Promontory Therapeutics Inc. at 7 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 22 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Recommended dose (RD) of PT-112 for further studies in patients with relapsed or refractory multiple myeloma (MM) (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 26 Apr 2022.