A Study of VLX1570 and Dexamethasone in Myeloma Patients

NCT02372240 | Terminated Phase 1

• 1 other identifier: V14-11056
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of VLX1570 with low dose dexamethasone

  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

  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

  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

  48 hours post dose

• Investigate Objective Response per International Myeloma Working Group criteria at any dose of VLX1570 with low dose dexamethasone.

  Pre-dose cycle 1, 2 and cycles on new dose, and in cycle 5 (or at time of CR or PD).

Other Outcomes (1)

• Blood, bone marrow and other tissues collected during study, will be used for biomarker and mechanism of action studies

  Pre-dose each day 16 of each new cycle on new dose and in cycle 5 (or at time of CR or PD)

Study Arms (1)

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

Drug: VLX1570 and dexamethasone

Interventions

VLX1570 and dexamethasone DRUG

VLX1570 and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vivolux AB: lead
• Theradex: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

VLX1570; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 26, 2015
• Study Start: April 8, 2015
• Primary Completion: May 24, 2017
• Study Completion: May 24, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)