SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma

NCT02661022 | Terminated Phase 1 Results DMC

• 1 other identifier: STML-401-0414
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In Relapsed and Refractory Multiple Myeloma

Conditions

Multiple Myeloma

Keywords

Relapsed or Relapsed and Refractory; Multiple Myeloma; CD123; SL-401/pom/dex; TAG/pom/dex; R/R; MM

Outcome Measures

Primary Outcomes (3)

• Number of Patients With Dose-limiting Toxicities and Treatment-emergent Adverse Events

  To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma

  For a 28-day cycle, Cycle 1

• Number of Patients With Treatment-related Adverse Events

  To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma

  Up to 12 months

• Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug

  To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (MM)

  Up to 12 Months

Secondary Outcomes (2)

• Overall Response Rate

  Up to 12 Months

• Progression-free Survival

  Up to 12 Months

Study Arms (2)

Phase 1, SL-401 7 µg/kg/day

EXPERIMENTAL

Dose Level 1: single-agent SL-401 7 µg/kg/day on Days 1-5 during the initial 28-day run-in cycle followed by a combination of SL-401/pomalidomide/dexamethasone (pom/dex) if there was no dose-limiting toxicity during the run-in cycle

Drug: SL-401 7 µg/kg/day

Phase 1, SL-401 9 µg/kg/day

EXPERIMENTAL

Dose Level 2: SL-401 9 µg/kg/day in combination with pom/dex

Drug: SL-401 9 µg/kg/day

Interventions

SL-401 7 µg/kg/day DRUG

SL-401 7 µg/kg/day in combination with pom/dex

Also known as: tagraxofusp-erzs

Phase 1, SL-401 7 µg/kg/day

SL-401 9 µg/kg/day DRUG

SL-401 9 µg/kg/day in combination with pom/dex

Also known as: tagraxofusp-erzs

Phase 1, SL-401 9 µg/kg/day

Eligibility Criteria

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

You may qualify if:

• Male or female patient who is at least 18 years of age.
• 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 MM based on standard criteria.
• Patient has received:
• At least 2 prior therapies including a proteasome inhibitor (≥ 2 cycles) and lenalidomide (≥ 2 cycles), and
• Has achieved at least stable disease (SD) for ≥ 1 cycle of treatment on ≥ 1 prior treatment, and
• Has demonstrated disease progression subsequent to treatment, during or within 90 days following completion of the most recent therapy.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
• Patient has measurable disease defined as at least 1 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)
• Absolute neutrophil count (ANC) ≥ 1000 cells/μl (growth factor cannot be used within the previous 7 days).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).
• Platelet count ≥ 50,000/μl (without platelet transfusion in the previous 7 days).

You may not qualify if:

• Patients will be ineligible for this study if they meet any 1 of the following criteria:
• The patient has an 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 Sponsor 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, organ-confined prostate cancer with no evidence of progressive disease.
• Prior therapy with SL-401 or received any investigational drug within the prior 30 days or 5 half-lives of the investigational drug, whichever is longer.
• Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within the prior 14 days except for alkylating agents (e.g., melphalan) within the prior 28 days.
• Pomalidomide (POM)-refractory disease (i.e., non-responsive to prior POM \[either as monotherapy or in combination\] or relapse/progressive disease within 60 days of prior POM (either as monotherapy or in combination). Prior POM exposure is permitted, provided the patient's MM is not considered POM-refractory as defined above.
• Primary refractory MM defined as disease that is non-responsive in patients that have never achieved at least stable disease or better with any therapy.
• Any \> grade 1 (according to the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], 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, or treatment with immunosuppressive therapy in the 2 months prior to study entry.
• Daily requirement for corticosteroids \>10 mg prednisone daily (or equivalent); inhaled corticosteroids are permitted.
• Patient is known to be human immunodeficiency virus 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, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)
• Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, 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, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of erythema multiforme or severe hypersensitivity to prior Immunomodulatory Drugs (IMiDs) such as thalidomide and lenalidomide.
• The patient is receiving medications that are strong inhibitors of CYP1A2. Patients should have discontinued strong CYP1A2 inhibitors (e.g., ciprofloxacin and fluvoxamine) at least 5 half-lives before beginning study drug.

Sponsors & Collaborators

• Stemline Therapeutics, Inc.: lead

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

Dana Farber Cancer Institue

Boston, Massachusetts, 02215, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

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MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

tagraxofusp

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated early due to slow accrual and changes to Sponsor's development program priorities. The third dose level (12 µg/kg/day), for Phase 2, was not investigated.

Results Point of Contact

• Title: Ira Gupta, MD, Senior Vice President, Clinical Development & Medical Affairs - Hematology
• Organization: Stemline Therapeutics, Inc.

clinicaltrials@menarinistemline.com

877-332-7967

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: January 21, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 17, 2024
• Results First Posted: November 9, 2023

Record last verified: 2024-03

Locations

US (3)