Status:
TERMINATED
First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in pa...
Eligibility Criteria
Inclusion
- Participants having Eastern Co-operative Oncology Group (ECOG) Performance Status less than or equals to (\<=) 1
- Adequate hematological, hepatic and renal function as defined in the protocol
- Participant must have measurable disease of Multiple Myeloma (MM) and received greater than (\>) 3 prior lines of therapy for MM including a Proteasome Inhibitors (PI), an Immunomodulatory Imide Drug (IMiD) and an anti-CD38 mAb or who are refractory to at least PI agent (carfilzomib or bortezomib) and IMiD according to the International Myeloma Working Group (IMWG) criteria
- Participant must have documented evidence progressive disease as defined by the IMWG criteria either on or after their last regimen
- Other protocol defined inclusion criteria could apply
Exclusion
- Any condition, including any uncontrolled disease state that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.
- An active second malignancy or evidence of disease of cancer (other than MM) before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).
- Cerebrovascular accident/stroke (\< 6 months prior enrollment) or neurologic instability per clinical evaluation due to tumor involvement of the Central Nervous System
- Diagnosis of fever within 1 week prior to study intervention administration
- Part B: Participants planning to undergo a stem cell transplant should not be enrolled to reduce disease burden prior to transplant.
- Other protocol defined exclusion criteria could apply
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04075721
Start Date
September 26 2019
End Date
April 1 2021
Last Update
March 24 2023
Active Locations (7)
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1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
2
Georgetown University Medical Center- Research Parent
Washington D.C., District of Columbia, United States, 20007
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203