ACTRN12607000584437CompletedPhase 2
A Prospective, Single-Arm, Two-Stage, Open-Label, Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to /A (—)
- Sex
- All
Inclusion Criteria
- •Diagnosis of multiple myeloma as per WHO (World Health Organisation) criteria.
- •Age 18 years or greater.
- •Patients must have received at least one but no more than 3 prior lines of myeloma therapy.
- •Patients must have failed to respond to the most recently administered anti-myeloma therapy or have demonstrably progressive disease by accepted clinical criteria.
- •Patients must have a life expectancy of at least 3 months.
- •ECOG (Eastern Co-operative Oncology Group) performance status <3.
- •Patients must be willing and able to given informed, written consent.
- •Patients must agree to use adequate contraceptive measures if indicated.
Exclusion Criteria
- •Patients with monoclonal gammopathy of undetermined significance.
- •Known or suspective hypersensitivity to CYT997.
- •Patient with uncontrolled intercurrent illness.
- •Patients who are pregnant or lactating.
- •Patient who have received other investigational agents within the preceding three weeks prior to starting therapy.
- •Patients with heart-attack or stroke within the preceding 6 months; unstable angina pectoris; history of diabetic retinopathy or major surgery in the preceding 30 days will be excluded.
- •Patients with a baseline prolongation of the QTc interval (QT interval corrected for heart rate) >450 msec.
- •Patients with impaired cardiac function or clinically significant cardiac disease.
- •Patients currently receiving treatment with medications known to prolong the QTc interval.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab (MOR00208) in Pediatric Patients with Relapsed or Refractory Acute B Lineage LeukemiaCTIS2024-511336-28-00niversitaetsklinikum Tuebingen AöR20
Active, not recruiting
Phase 1
Tafasitamab against childhood leukemiaB-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL) refractory to standard treatment or with relapsed diseaseMedDRA version: 20.0Level: LLTClassification code 10024338Term: Leukemia lymphoblastic acuteSystem Organ Class: 100000004864EUCTR2022-000557-88-DEniversity Hospital Tuebingen39
Completed
Phase 2
A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic LeukemiaRare & aggressive T-lymphoid malignancyT-Cell Prolymphocytic Leukemia10024324NL-OMON50080AbbVie Deutschland GmbH & Co. KG4
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy of Venetoclax plus Ibrutinib in Participants With T-Cell Prolymphocytic LeukemiaEUCTR2018-002179-17-ATAbbVie Deutschland GmbH & Co. KG37
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy of Venetoclax plus Ibrutinib in Participants With T-Cell Prolymphocytic LeukemiaEUCTR2018-002179-17-FIAbbVie Deutschland GmbH & Co. KG37