Multiple MyelomaPhase 1NCT03143985
Vactosertib in Combination w/ Pomalidomide in Relapsed or Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing Vactosertib and Pomalidomide in people with Multiple Myeloma, run by Koen van Besien at 1 site in United States.
Trial summary
The purpose of this study is to see if the study drug, called Vactosertib, is safe and determine what the best dose is to treat future patients when given in combination with pomalidomide (POM). The study will also look to see if it has any effect on multiple myeloma, when given in combination with POM. 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?
- Vactosertib and Pomalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 1 Sep 2022
- 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
- Patient has given voluntary written informed consent before performance of any study-related procedures not part of standard (non-investigational) medical care.
- Patient has been previously diagnosed with multiple myeloma based on standard criteria.
- Patient has relapsed or refractory disease according to international uniform response criteria and must have previously received therapy with:
- A proteasome inhibitor and Immunomodulatory imide drugs (IMiD)
- All subjects must have documented disease progression during or after their last antimyeloma therapy.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
Show all 18Show fewer
- Patient has measurable disease defined as at least one of the following:
- Serum M protein ≥ 0.5 /dL (≥5 g/L)
- Urine M protein ≥ 200 mg/24 hours
- Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
- Clinical Laboratory Inclusion Criteria: The following laboratory results must be met within 14 days (or as stipulated) prior to study drug (treatment) administration:
- Absolute neutrophil count (ANC) ≥ 1000 cells/μl (growth factor cannot be used within the previous 5 days)
- Platelet count ≥ 50,000/μl (without platelet transfusion in the previous 5 days)
- Aspartate aminotransferase (AST/SGOT) and Alanine aminotransferase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN)
- Serum total bilirubin ≤ 2.0 mg/dL or >3.0 x ULN for subjects with hereditary benign hyperbilirubinemia
- Creatinine clearance ≥ 30 ml/min (calculated by the Cockcroft-Gault Equation or per 24 hour urine collection)
- Serum calcium (corrected for albumin) level at or below the ULN range (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal range with standard treatment).
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test prior to initiation of the study treatment with Vactosertib/POM. The test must have a sensitivity of at least 50 mIU/mL. Study participants who are FCBP must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking POM through 30 days after the last dose of POM and 60 days after the last dose of Vactosertib. FCBP must also agree to ongoing pregnancy testing during the entire duration of treatment. Men must agree to use a latex or synthetic condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 60 days after the last dose of POM or Vactosertib. These same patients must not donate sperm. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. All patients enrolled into this trial, must agree to be registered in and must comply with all requirements of the Pomalidomide Risk Evaluation and Mitigation Strategy (POM REMS™) program.
Who cannot join
- Prior therapy with Vactosertib or received any investigational drug within the prior 28 days.
- Plasma Cell Leukemia
- Patients with solitary plasmacytoma
- Patients who are primarily eligible for autologous stem cell transplant
- Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within the prior 21 days except for alkylating agents (e.g., melphalan) within the prior 28 days.
- Prior treatment with pomalidomide.
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- Subjects with active malignancy and/or cancer history that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) with substantial potential for recurrence and/or ongoing active malignancy must be discussed with the trial collaborator, MedPacto Inc., before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, and organ-confined prostate cancer with no evidence of progressive disease
- Any > grade 1 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) v.4.03) adverse reaction unresolved from previous treatments or not readily managed and controlled with supportive care. The presence of alopecia of any grade and peripheral neuropathy ≤ Grade 2 without pain is allowed.
- Previous allogeneic stem cell transplantation with active graft versus host disease (GVHD), or treatment with immunosuppressive therapy in the 2 months prior to study entry.
- No oral corticosteroids 3 days before initiating combinations Vactosertib/POM; inhaled corticosteroids are permitted.
- Patient is known to be human immunodeficiency virus (HIV) positive, or have chronic or active Hepatitis B (core- or surface antigen-positive) or active hepatitis C infection.
- Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association (NYHA) Class 3 or 4, congestive heart failure, uncontrolled or unstable angina, history of myocardial infarction or stroke within 6 months prior to study entry, or clinically significant arrhythmias not controlled by medication).
- Major abnormalities identified by ECG or echocardiogram (ECHO), at the Investigator's discretion.
- Presence of aneurisms of the ascending aorta or aortic stress.
- Hypertension that is not controlled by standard medication (to 150/90 mmHg or below).
- Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), pulmonary hypertension) that in the opinion of the investigator would put the patient at significant risk for pulmonary complications during the study.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation (DIC), or psychiatric illness/social situations that would limit compliance with study requirements.
- History of erythema multiforme or severe hypersensitivity to prior IMiD's such as thalidomide and lenalidomide.
- Patients requiring hemodialysis
- The patient is receiving medications that are:
- Exclusively or primarily eliminated by cytochrome P-450 isozyme 3A4 (CYP3A4).
- Exclusively or primarily eliminated by Uridine 5'-diphospho (UDP)-glucuronyltransferase 1A1 (UGT1A1).
- Substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window; or which are strong inhibitors of drug transporter MDR1.
- Patients should have discontinued strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine) at least five half-lives before beginning study treatment.
- Inability to tolerate thromboprophylaxis (Required Concurrent Medications)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: A Phase 1b Trial of Vactosertib in Combination With Pomalidomide (POM) in Relapsed or Relapsed and Refractory Multiple Myeloma (RRMM)
The purpose of this study is to see if the study drug, called Vactosertib, is safe and determine what the best dose is to treat future patients when given in combination with pomalidomide (POM). The study will also look to see if it has any effect on multiple myeloma, when given in combination with POM.
Read the detailed description
Primary Objective
- To determine the maximum tolerated dose (MTD) or maximum tested dose level of Vactosertib given in combination with pomalidomide (POM) for the treatment of relapsed or relapsed or refractory multiple myeloma (RRMM)
- To characterize the safety and tolerability profile of Vactosertib in combination with POM at the MTD
Secondary Objectives
To evaluate the activity of the combination of Vactosertib/POM regimen in terms of:
- Overall response rate (complete response [CR] + very good partial response [VGPR] +partial response [PR]) and clinical benefit rate (CR + VGPR + PR + minimal response [MR]) based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (DOR) in RRMM patients.
- Progression-free survival (PFS) and PFS at 6 months (PFS-6)
Exploratory Objective:
To evaluate the bone remodeling and immunologic effects of POM/Vactosertib combination therapy and its correlation with clinical outcome in patients with multiple myeloma.
Study Design To evaluate the bone remodeling and immunologic effects of POM/Vactosertib combination therapy and its correlation with clinical outcome in patients with multiple myeloma. This study is a Phase I, open label trial of Vactosertib in combination with standard doses of POM. The study will be conducted as a modified Fibonacci 3 + 3 dose escalation design to determine the MTD of Vactosertib in combination with standard doses of POM. Patients will receive combination Vactosertib/POM.
- Conditions
- Multiple Myeloma
- Being tested
- Vactosertib, Pomalidomide
- Keywords
- Vactosertib, Pomalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VactosertibDrug
Also called TEW-7197, EW7197, EW-7197
Vactosertib is an inhibitor of protein serine/threonine kinase activity of TGF-β receptor type 1 (TGFBR1; ALK5). Vactosertib inhibits the phosphorylation of the ALK5 substrates, Smad2 and Smad3, and the intracellular signaling of TGF-β. Dosing begins at 60mg by mouth, daily and may increase to 240mg by mouth daily in the absence of dose limiting toxicities
PomalidomideDrug
Also called POM
POM, an analog of thalidomide, is an immunomodulatory agent with antineoplastic activity. Myeloma tumor cells exposed to POM, undergo growth arrest and increased apoptotic cell death. POM enhances T cell- and natural killer cell-mediated immunity and inhibit production of pro-inflammatory cytokines by monocytes. POM may be taken orally with water. Capsules should not be broken, chewed or opened. POM should be taken without food (at least 2 hours before or 2 hours after a meal). POM will be commercially available. POM will be taken by mouth at a dose of 4mg per day
| Study group | Role | What they receive |
|---|---|---|
| Vactosertib + Pomalidomide | Experimental | Vactosertib tablets, taken once daily for the first and second dose levels and twice a day for third and fourth dose level levels for 5 days followed by 2 days without treatment, repeated for 28-day cycles until evidence of progressive disease, intolerable toxicity, or participant discontinuation.
For dose escalation - dosing initiated at 60 mg once daily by oral administration and will be increased to determine MTD. Provisional subsequent doses are 60, 120, once daily and 100 mg and 200 mg twice daily on days 1-5, 8-12, 15-19 and 22-26. Extension cohorts will enter at 200 mg twice daily (i.e. if MTD not defined) for 12 months until progression or intolerable toxicity.
POM is administered orally (4 mg/day daily on Days 1 - 21 days). Treatment will occur in a suitable outpatient ambulatory care setting that is equipped for monitoring of patients with hematopoietic malignancies undergoing early clinical trial research. Receives: Drug: Vactosertib; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) or maximum tested dose level of Vactosertib given in combination with POM for the treatment of relapsed or RRMM
the largest tested dose where multiple dose limiting toxicities are not observed
Measured: Up to 30 days after treatment ends (24 weeks + 30 days)
Secondary outcomes (6)
Overall response rate
overall response is the complete response [CR] + very good partial response [VGPR] + partial response [PR] based on International Myeloma Working Group (IMWG) defined response criteria
Measured: Up to 6 months after beginning treatment
Progression-free survival (PFS)
Progression-free survival will be measured from study entry to progression or death of any cause, whichever comes first.
Measured: Up to 30 days after discontinuation of treatment
Progression-free survival at 6 months (PFS-6)
Number of patients who did not progress on treatment, at 6 months after beginning treatment
Measured: Up to 6 months after beginning treatment
Duration of Response
The time from the first confirmed response to progression of disease. Responses include Complete Response (CR), Stringent CR, Very Good Partial Response, Partial Response, Minor Response, Stable disease. Responses based on International Myeloma Working Group (IMWG) defined response criteria
Measured: Up to 6 months after beginning treatment
clinical benefit rate
clinical benefit rate is the CR + VGPR + PR + minimal response [MR] based on International Myeloma Working Group (IMWG) defined response criteria
Measured: Up to 6 months after beginning treatment
Overall Survival
Overall survival for all will be measured from study entry to death from any cause
Measured: Up to 6 months after progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start21 Jul 2017
- Primary completion27 Feb 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koen van Besien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Koen van Besien, Case Comprehensive Cancer Center
- Investigators
- Koen van Besien, MD, PhD, Principal investigator, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143985
- Sponsor's protocol ID
- CASE1A17
- Status last verified
- May 2024
- First submitted
- 4 May 2017
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Malek E, Rana PS, Swamydas M, Daunov M, Miyagi M, Murphy E, Ignatz-Hoover JJ, Metheny L, Kim SJ, Driscoll JJ. The TGFbeta type I receptor kinase inhibitor vactosertib in combination with pomalidomide in relapsed/refractory multiple myeloma: a phase 1b trial. Nat Commun. 2024 Aug 27;15(1):7388. doi: 10.1038/s41467-024-51442-2.
PubMed 39191755
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of Vactosertib in Combination With Pomalidomide (POM) in Relapsed or Relapsed and Refractory Multiple Myeloma (RRMM)
- ClinicalTrials.gov ID
- NCT03143985
- Acronym / sponsor ID
- CASE1A17
- Conditions
- Multiple Myeloma
- Keywords
- Vactosertib, Pomalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Koen van BesienUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 8 May 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.
The purpose of this study is to see if the study drug, called Vactosertib, is safe and determine what the best dose is to treat future patients when given in combination with pomalidomide (POM). The study will also look to see if it has any effect on multiple myeloma, when given in combination with POM.
Detailed description
Primary Objective
- To determine the maximum tolerated dose (MTD) or maximum tested dose level of Vactosertib given in combination with pomalidomide (POM) for the treatment of relapsed or relapsed or refractory multiple myeloma (RRMM)
- To characterize the safety and tolerability profile of Vactosertib in combination with POM at the MTD
Secondary Objectives
To evaluate the activity of the combination of Vactosertib/POM regimen in terms of:
- Overall response rate (complete response [CR] + very good partial response [VGPR] +partial response [PR]) and clinical benefit rate (CR + VGPR + PR + minimal response [MR]) based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (DOR) in RRMM patients.
- Progression-free survival (PFS) and PFS at 6 months (PFS-6)
Exploratory Objective:
To evaluate the bone remodeling and immunologic effects of POM/Vactosertib combination therapy and its correlation with clinical outcome in patients with multiple myeloma.
Study Design To evaluate the bone remodeling and immunologic effects of POM/Vactosertib combination therapy and its correlation with clinical outcome in patients with multiple myeloma. This study is a Phase I, open label trial of Vactosertib in combination with standard doses of POM. The study will be conducted as a modified Fibonacci 3 + 3 dose escalation design to determine the MTD of Vactosertib in combination with standard doses of POM. Patients will receive combination Vactosertib/POM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vactosertib + Pomalidomide | Experimental | Drug: Vactosertib, Drug: PomalidomideVactosertib tablets, taken once daily for the first and second dose levels and twice a day for third and fourth dose level levels for 5 days followed by 2 days without treatment, repeated for 28-day cycles until evidence of progressive disease, intolerable toxicity, or participant discontinuation. For dose escalation - dosing initiated at 60 mg once daily by oral administration and will be increased to determine MTD. Provisional subsequent doses are 60, 120, once daily and 100 mg and 200 mg twice daily on days 1-5, 8-12, 15-19 and 22-26. Extension cohorts will enter at 200 mg twice daily (i.e. if MTD not defined) for 12 months until progression or intolerable toxicity. POM is administered orally (4 mg/day daily on Days 1 - 21 days). Treatment will occur in a suitable outpatient ambulatory care setting that is equipped for monitoring of patients with hematopoietic malignancies undergoing early clinical trial research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient has given voluntary written informed consent before performance of any study-related procedures not part of standard (non-investigational) medical care.
- Patient has been previously diagnosed with multiple myeloma based on standard criteria.
- Patient has relapsed or refractory disease according to international uniform response criteria and must have previously received therapy with:
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- Patient has measurable disease defined as at least one of the following:
Key exclusion criteria (25 listed)
- Prior therapy with Vactosertib or received any investigational drug within the prior 28 days.
- Plasma Cell Leukemia
- Patients with solitary plasmacytoma
- Patients who are primarily eligible for autologous stem cell transplant
- Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within the prior 21 days except for alkylating agents (e.g., melphalan) within the prior 28 days.
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 |
|---|---|---|
| VactosertibAlso: TEW-7197, EW7197, EW-7197Vactosertib is an inhibitor of protein serine/threonine kinase activity of TGF-β receptor type 1 (TGFBR1; ALK5). Vactosertib inhibits the phosphorylation of the ALK5 substrates, Smad2 and Smad3, and the intracellular signaling of TGF-β. Dosing begins at 60mg by mouth, daily and may increase to 240mg by mouth daily in the absence of dose limiting toxicities | Drug | Vactosertib + Pomalidomide |
| PomalidomideAlso: POMPOM, an analog of thalidomide, is an immunomodulatory agent with antineoplastic activity. Myeloma tumor cells exposed to POM, undergo growth arrest and increased apoptotic cell death. POM enhances T cell- and natural killer cell-mediated immunity and inhibit production of pro-inflammatory cytokines by monocytes. POM may be taken orally with water. Capsules should not be broken, chewed or opened. POM should be taken without food (at least 2 hours before or 2 hours after a meal). POM will be commercially available. POM will be taken by mouth at a dose of 4mg per day | Drug | Vactosertib + Pomalidomide |
Primary outcome
To determine the maximum tolerated dose (MTD) or maximum tested dose level of Vactosertib given in combination with POM for the treatment of relapsed or RRMM
Time frame: Up to 30 days after treatment ends (24 weeks + 30 days)
the largest tested dose where multiple dose limiting toxicities are not observed
6 secondary outcomes
Overall response rate
Time frame: Up to 6 months after beginning treatment
Progression-free survival (PFS)
Time frame: Up to 30 days after discontinuation of treatment
Progression-free survival at 6 months (PFS-6)
Time frame: Up to 6 months after beginning treatment
Duration of Response
Time frame: Up to 6 months after beginning treatment
clinical benefit rate
Time frame: Up to 6 months after beginning treatment
Overall Survival
Time frame: Up to 6 months after progression
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 24 May 2024.
- Derived from this study: PubMed 39191755Malek E, Rana PS, Swamydas M, Daunov M, Miyagi M, Murphy E, Ignatz-Hoover JJ, Metheny L, Kim SJ, Driscoll JJ. The TGFbeta type I receptor kinase inhibitor vactosertib in combination with pomalidomide in relapsed/refractory multiple myeloma: a phase 1b trial. Nat Commun. 2024 Aug 27;15(1):7388. doi: 10.1038/s41467-024-51442-2.
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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.
Koen van Besien, MD, PhD principal investigator
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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 Vactosertib and Pomalidomide in people with Multiple Myeloma, run by Koen van Besien 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 18 inclusion and 25 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 24 May 2024. 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?
To determine the maximum tolerated dose (MTD) or maximum tested dose level of Vactosertib given in combination with POM for the treatment of relapsed or RRMM (time frame: Up to 30 days after treatment ends (24 weeks + 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143985, which also lists 1 linked publication.
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 24 May 2024.