Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04918511
Other study ID # OP-501
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date May 27, 2021
Est. completion date December 2025

Study information

Verified date November 2021
Source Oncopeptides AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of a single infusion of OPD5 before Autologous Stem Cell Transplant in patients with RRMM. The study will evaluate increasing doses of OPD5 to find the best dose and to assess any side effects. Each patient will be assigned to a dose cohort of 3-6 patients to receive one single dose of OPD5. Each patient will be hospitalized for about 14 days from the OPD5 infusion and then have monthly visits to the clinic for 3 months and then every third month until disease progression or starting new myeloma treatment, maximum up to 2 years.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2025
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female, between the ages of 18 years and 70 years at the planned time of study treatment; patients greater than 70 years of age may qualify on a case by case basis - Diagnosis of multiple myeloma - Received a previous Autologous Stem Cell Transplantation ( ASCT) (single or tandem) that resulted in disease progression within 24 months - Received at least 2 prior lines of therapy - Refractory to previous treatment with a Proteasome Inhibitor (PI), an immunomodulatory drug (IMiD) and an anti-Cluster of Differentiation 38 monoclonal antibody (anti-CD38 mAb) - Male and women of childbearing potential agrees to use contraception during the treatment period and during a specified time period after the last dose Exclusion Criteria: - Prior treatment with melphalan flufenamide (melflufen) or OPD5 - Any medical condition that may interfere with safety or participation in this study - Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance - Prior allogeneic stem cell transplantation or prior salvage ASCT

Study Design


Intervention

Drug:
OPD5
OPD5 solution for i.v. infusion

Locations

Country Name City State
Czechia University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology Brno
Czechia University Hospital Ostrava, Clinic of Hematooncology Ostrava
Czechia Charles University and General Hospital in Prague, 1st Department of Medicine - Department of Hematology, First Faculty of Medicine Praha

Sponsors (1)

Lead Sponsor Collaborator
Oncopeptides AB

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and grade of Treatment Emergent Adverse Events (TEAEs) Including frequency and grade of defined Dose Limiting Toxicities 30 days post OPD5 treatment with ASCT
Primary Incidence of clinically significant changes in clinical laboratory parameters 30 days post OPD5 treatment with ASCT
Primary Magnitude of clinically significant changes in clinical laboratory parameters 30 days post OPD5 treatment with ASCT
Primary Incidence of clinically significant adverse findings in vital signs 30 days post OPD5 treatment with ASCT
Primary Severity of clinically significant adverse findings in vital signs 30 days post OPD5 treatment with ASCT
Primary Incidence of clinically significant adverse findings in electrocardiograms (ECGs) 30 days post OPD5 treatment with ASCT
Primary Severity of clinically significant adverse findings in electrocardiograms (ECGs) 30 days post OPD5 treatment with ASCT
Primary Incidence of clinically significant adverse findings in other physical examination parameters 30 days post OPD5 treatment with ASCT
Primary Severity of clinically significant adverse findings in other physical examination parameters 30 days post OPD5 treatment with ASCT
Primary Incidence of mucositis 30 days post OPD5 treatment with ASCT
Primary Severity of mucositis Using World Health Organization (WHO) oral toxicity scale, from 0 (no change) to 4 (oral feeding is not possible) 30 days post OPD5 treatment with ASCT
Primary The number of deaths not related to relapse or progression 100 days post OPD5 treatment with ASCT
Secondary Best Response Best response for a single patient. Best response will include the following categories: stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) and Progressive Disease (PD) as assessed by the investigator according to International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 30 days post OPD5 treatment with ASCT
Secondary Overall Response Rate (ORR) Proportion of patients who achieve response of CR, sCR, VGPR or PR as their best response. approximately 100 days post OPD5 treatment with ASCT
Secondary Duration of response (DOR) Time from the first confirmed response of sCR, CR, VGPR or PR to first confirmed disease progression, or death due to any cause approximately 12 months
Secondary Time to progression (TTP) Time from the date of OPD5 administration to the date of the first documented confirmed PD approximately 12 months
Secondary Time to next treatment (TTNT) Time from the date of OPD5 administration start to the start of first post study myeloma therapy (maintenance MM treatment not considered as new line of therapy) approximately 12 months
Secondary Progression Free Survival (PFS) Time from the date of OPD5 dosing to the date of first documentation of confirmed progressive disease (PD) or death due to any cause approximately 12 months
Secondary Pharmacokinetics Area under the curve AUC(0-t) for OPD5 and the metabolites desethyl-melflufen and melphalan Day -1 (the day of OPD5 infusion)
Secondary Pharmacokinetics AUC(0-infinity) for OPD5 and the metabolites desethyl-melflufen and melphalan Day -1 (the day of OPD5 infusion)
Secondary Pharmacokinetics elimination half-life (t½) for OPD5 and the metabolites desethyl-melflufen and melphalan Day -1 (the day of OPD5 infusion)
Secondary Pharmacokinetics Cmax for OPD5 and the metabolites desethyl-melflufen and melphalan Day -1 (the day of OPD5 infusion)
Secondary Time to hematological recovery defined as the return of Absolute Neutrophil Count (ANC) = 0.5 x 10^9/L and platelets = 20 x 10^9/L for two consecutive days approximately Day 14
Secondary Time to myeloablation defined as the first of at least two consecutive days with ANC < 0.5 x 10^9/L and platelets <20 x 10^9/L approximately Day 14
Secondary Minimal Residual Disease (MRD) status by Next Generation sequencing (NGS) in patients that achieve a CR or VGPR. approximately Day 100
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1