Multiple MyelomaPhase 1/2NCT02372240
A Study of VLX1570 and Dexamethasone in Myeloma Patients
A Phase 1/2 study testing VLX1570 and dexamethasone in people with Multiple Myeloma, run by Vivolux AB at 1 site in United States.
Trial summary
This is a phase 1/2 single arm study to determine the safety and efficacy of VLX1570 IV infusion administered with low dose dexamethasone in patients with relapsed or relapsed and 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?
- VLX1570 and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2015to 24 May 2017
- 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
- Diagnosis of relapsed or relapsed and refractory multiple myeloma following at least 2 prior therapies which must include at least one immunomodulatory drug (e.g., thalidomide, lenalidomide or pomalidomide) and one proteasome inhibitor (e.g., bortezomib or carfilzomib). Patients must not be candidates for regimens known to provide clinical benefit.
- Measurable disease defined by 1 or more of the following:
- Serum monoclonal protein ≥ 0.5 g/dL
- Urine monoclonal protein >200 mg/24 hour
- Serum immunoglobulin free light chain >10 mg/dL AND abnormal kappa/lambda ratio (reference 0.26-1.65)
- Estimated glomerular filtration rate (GFR) ≥30 mL/min as assessed by CKD-epi, MDRD or the Cockcroft-Gault Equation
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- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Females of child-bearing potential* must have a negative pregnancy test.
- Males and females of child-bearing potential*, willing to use an effective form of contraception during chemotherapy treatment and for at least 6 months thereafter. Such methods include: (if using hormonal contraception this method must be supplemented with a barrier method, preferably male condom)
- oral, intra-vaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition for ovulation
- oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception.
- Absolute neutrophil count (ANC) ≥1.0 x 109 /L, hemoglobin ≥8 g/dL, and platelet count ≥ 75 x 109/L.
- Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN.
- Patient has or is willing to have a central venous catheter (e.g. PICC, Port-A-Cath®, Hickman® catheter) for drug administration.
Who cannot join
- Any concurrent treatment that would compromise the study including but not limited to:
- Planned concurrent treatment for multiple myeloma other than bisphosphonates
- Ongoing corticosteroids for indications other than multiple myeloma allowed as long as the dose does not exceed 10 mg of prednisone per day or equivalent
- Persisting effects of any previous or ongoing treatment ≥ grade 1 that might compromise delivery of study treatment or assessment of adverse events (except alopecia or neuropathy ≤ grade 2 without pain)
- Any cytotoxic or biologic therapy less than 2 weeks prior to initiation of therapy.
- Pregnant or breast feeding females.
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- Uncontrolled hypertension or diabetes.
- Known active hepatitis B or C infection or HIV infection.
- Significant cardiovascular disease with NYHA Class III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or myocardial infarction within 6 months prior to enrollment, or unstable angina, or unstable arrhythmia.
- QTc interval >460 msec (males) or >470 msec (females); or repeated demonstration of a QTc interval >450 msec.
- A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval.
- Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that, in the opinion of the Investigator, would compromise compliance of study requirements or put the patient at unacceptable risk.
- Active infection requiring systemic treatment within one week prior to first dose.
- Major surgery within 1 month prior to enrollment.
- Use of any investigational agent within the last 28 days. For classes of investigational agents that are not known to have prolonged toxicities the wash-out time may be decreased to 14 days after agreement with the Medical Monitor.
- History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy for at least 2 years.
- Known intolerance to steroids or H1/H2-antagonists.
- Serum calcium (corrected for albumin) level above the ULN range (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal with standard treatment).
- Diagnosed with plasma cell leukemia, POEMS syndrome or amyloidosis.
- Patients with a history of ventral nervous system (CNS) myeloma or other CNS malignancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: VLX1570 and Low-Dose Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma: A Clinical and Correlative Phase 1/2 Study
This is a phase 1/2 single arm study to determine the safety and efficacy of VLX1570 IV infusion administered with low dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma.
Read the detailed description
This is a phase 1/2, open label study to determine the safety and efficacy of VLX1570 intravenous (IV) infusion administered with low dose dexamethasone on days 1, 2, 8, 9, 15, 16 of a 28-day cycle in patients with confirmed diagnosis of multiple myeloma with relapsed or relapsed and refractory disease (RRMM).
The phase 1 trial design follows an Initial Accelerated Titration design followed by a traditional "3+3" cohort design to establish maximum tolerated dose (MTD) and recommended phase 2 dose (RPTD) for the phase 2 portion of the study. It is anticipated that patients will receive 6 treatment cycles. In the absence of unacceptable toxicity and disease progression, patients have the option of continuing treatment beyond 6 cycles, if the investigator determines that the patient may benefit further from it.
- Conditions
- Multiple Myeloma
- Being tested
- VLX1570 and dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLX1570 and dexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| VLX1570 and dexamethasone | Experimental | VLX1570 IV (0.05, 0.15, 0.3, 0.6, 1.2, 2.0 mg/kg) on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Dexamethasone 20 mg PO/IV Receives: Drug: VLX1570 and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of VLX1570 with low dose dexamethasone
Measured: Duration of treatment (expected avg. 6 months) and up to 30 days following the last dose/off-study
Clinical benefit rate (minimal response or better) in patients associated with administration of VLX1570 with low dose dexamethasone
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Secondary outcomes (3)
Frequency and severity of adverse events associated with the combination of VLX1570 and low dose dexamethasone
Measured: Duration of treatment (expected avg. 6 months) and up to 30 days following the last dose/off-study
Pharmacokinetic profile of VLX1570 following IV infusion
PK parameters include Cmax, Tmax, AUC, half-life, clearance
Measured: 48 hours post dose
Investigate Objective Response per International Myeloma Working Group criteria at any dose of VLX1570 with low dose dexamethasone.
SPEP/UPEP, IFE, SFLC
Measured: Pre-dose cycle 1, 2 and cycles on new dose, and in cycle 5 (or at time of CR or PD).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study start8 Apr 2015
- Primary completion24 May 2017
- Study completion24 May 2017
Why it stopped: Dose limiting tox is observed. Study put on full clinical hold.
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivolux AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372240
- Sponsor's protocol ID
- V14-11056
- Status last verified
- May 2018
- First submitted
- 5 Feb 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VLX1570 and Low-Dose Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma: A Clinical and Correlative Phase 1/2 Study
- ClinicalTrials.gov ID
- NCT02372240
- Acronym / sponsor ID
- V14-11056
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dose limiting tox is observed. Study put on full clinical hold.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vivolux ABIndustry (pharma, biotech, devices)
- Collaborators
- Theradex
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 26 Feb 2015 (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.
This is a phase 1/2 single arm study to determine the safety and efficacy of VLX1570 IV infusion administered with low dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma.
Detailed description
This is a phase 1/2, open label study to determine the safety and efficacy of VLX1570 intravenous (IV) infusion administered with low dose dexamethasone on days 1, 2, 8, 9, 15, 16 of a 28-day cycle in patients with confirmed diagnosis of multiple myeloma with relapsed or relapsed and refractory disease (RRMM).
The phase 1 trial design follows an Initial Accelerated Titration design followed by a traditional "3+3" cohort design to establish maximum tolerated dose (MTD) and recommended phase 2 dose (RPTD) for the phase 2 portion of the study. It is anticipated that patients will receive 6 treatment cycles. In the absence of unacceptable toxicity and disease progression, patients have the option of continuing treatment beyond 6 cycles, if the investigator determines that the patient may benefit further from it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VLX1570 and dexamethasone | Experimental | Drug: VLX1570 and dexamethasoneVLX1570 IV (0.05, 0.15, 0.3, 0.6, 1.2, 2.0 mg/kg) on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle Dexamethasone 20 mg PO/IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Diagnosis of relapsed or relapsed and refractory multiple myeloma following at least 2 prior therapies which must include at least one immunomodulatory drug (e.g., thalidomide, lenalidomide or pomalidomide) and one proteasome inhibitor (e.g., bortezomib or carfilzomib). Patients must not be candidates for regimens known to provide clinical benefit.
- Measurable disease defined by 1 or more of the following:
- Estimated glomerular filtration rate (GFR) ≥30 mL/min as assessed by CKD-epi, MDRD or the Cockcroft-Gault Equation
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Key exclusion criteria (21 listed)
- Any concurrent treatment that would compromise the study including but not limited to:
- Any cytotoxic or biologic therapy less than 2 weeks prior to initiation of therapy.
- Pregnant or breast feeding females.
- Uncontrolled hypertension or diabetes.
- Known active hepatitis B or C infection or HIV infection.
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 |
|---|---|---|
| VLX1570 and dexamethasone | Drug | VLX1570 and dexamethasone |
Primary outcome
Maximum tolerated dose (MTD) of VLX1570 with low dose dexamethasone
Time frame: Duration of treatment (expected avg. 6 months) and up to 30 days following the last dose/off-study
Clinical benefit rate (minimal response or better) in patients associated with administration of VLX1570 with low dose dexamethasone
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
3 secondary outcomes
Frequency and severity of adverse events associated with the combination of VLX1570 and low dose dexamethasone
Time frame: Duration of treatment (expected avg. 6 months) and up to 30 days following the last dose/off-study
Pharmacokinetic profile of VLX1570 following IV infusion
Time frame: 48 hours post dose
Investigate Objective Response per International Myeloma Working Group criteria at any dose of VLX1570 with low dose dexamethasone.
Time frame: Pre-dose cycle 1, 2 and cycles on new dose, and in cycle 5 (or at time of CR or PD).
Results and safety
The study was stopped early (reason given: Dose limiting tox is observed. Study put on full clinical hold.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 VLX1570 and dexamethasone in people with Multiple Myeloma, run by Vivolux AB 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 20 inclusion and 21 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: stopped early, as of the sponsor's last update on 11 May 2018. 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 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?
The study was stopped early (reason given: Dose limiting tox is observed. Study put on full clinical hold.). Results are not available in the source record.
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?
Maximum tolerated dose (MTD) of VLX1570 with low dose dexamethasone (time frame: Duration of treatment (expected avg. 6 months) and up to 30 days following the last dose/off-study). The study lists 2 primary outcomes in all. 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 11 May 2018.