A Phase 1 interventional study of OPD5 in Relapse Multiple Myeloma and Multiple Myeloma, sponsored by Oncopeptides AB. Withdrawn at 3 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Oncopeptides AB · Phase 1, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
Browse Multiple Myeloma studies →Oncopeptides AB is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
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In dose cohort 1, treatment with OPD5 solution will be given as one single i.v. infusion over 30 minutes at a dose level of 30 mg/m2 (dose based on body surface area)
Drug: OPD5
In dose cohort 2, treatment with OPD5 solution will be given as one single i.v. infusion over 30 minutes at a dose level decided based on the results from Dose Cohort 1
Drug: OPD5
In dose cohort 3, treatment with OPD5 solution will be given as one single i.v. infusion over 30 minutes at a dose level decided based on the results from Dose Cohort 2
Drug: OPD5
In dose cohort 4, treatment with OPD5 solution will be given as one single i.v. infusion over 30 minutes at a dose level decided based on the results from Dose Cohort 3
Drug: OPD5
In dose cohort 5, treatment with OPD5 solution will be given as one single i.v. infusion over 30 minutes at a dose level decided based on the results from Dose Cohort 4
Drug: OPD5
In dose cohort 6, treatment with OPD5 solution will be given as one single i.v. infusion over 30 minutes at a dose level decided based on the results from Dose Cohort 5
Drug: OPD5
In dose cohort 7, treatment with OPD5 solution will be given as one single i.v. infusion over 30 minutes at a dose level decided based on the results from Dose Cohort 6
Drug: OPD5
OPD5 solution for i.v. infusion
Incidence and grade of Treatment Emergent Adverse Events (TEAEs)
Including frequency and grade of defined Dose Limiting Toxicities
Time frame: 30 days post OPD5 treatment with ASCT
Incidence of clinically significant changes in clinical laboratory parameters
Time frame: 30 days post OPD5 treatment with ASCT
Magnitude of clinically significant changes in clinical laboratory parameters
Time frame: 30 days post OPD5 treatment with ASCT
Incidence of clinically significant adverse findings in vital signs
Time frame: 30 days post OPD5 treatment with ASCT
Severity of clinically significant adverse findings in vital signs
Time frame: 30 days post OPD5 treatment with ASCT
Incidence of clinically significant adverse findings in electrocardiograms (ECGs)
Time frame: 30 days post OPD5 treatment with ASCT
Severity of clinically significant adverse findings in electrocardiograms (ECGs)
Time frame: 30 days post OPD5 treatment with ASCT
Incidence of clinically significant adverse findings in other physical examination parameters
Time frame: 30 days post OPD5 treatment with ASCT
Severity of clinically significant adverse findings in other physical examination parameters
Time frame: 30 days post OPD5 treatment with ASCT
Incidence of mucositis
Time frame: 30 days post OPD5 treatment with ASCT
Severity of mucositis
Using World Health Organization (WHO) oral toxicity scale, from 0 (no change) to 4 (oral feeding is not possible)
Time frame: 30 days post OPD5 treatment with ASCT
The number of deaths not related to relapse or progression
Time frame: 100 days post OPD5 treatment with ASCT
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)
Time frame: 30 days post OPD5 treatment with ASCT
Overall Response Rate (ORR)
Proportion of patients who achieve response of CR, sCR, VGPR or PR as their best response.
Time frame: approximately 100 days post OPD5 treatment with ASCT
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
Time frame: approximately 12 months
Time to progression (TTP)
Time from the date of OPD5 administration to the date of the first documented confirmed PD
Time frame: approximately 12 months
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)
Time frame: approximately 12 months
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
Time frame: approximately 12 months
Pharmacokinetics Area under the curve AUC(0-t) for OPD5 and the metabolites desethyl-melflufen and melphalan
Time frame: Day -1 (the day of OPD5 infusion)
Pharmacokinetics AUC(0-infinity) for OPD5 and the metabolites desethyl-melflufen and melphalan
Time frame: Day -1 (the day of OPD5 infusion)
Pharmacokinetics elimination half-life (t½) for OPD5 and the metabolites desethyl-melflufen and melphalan
Time frame: Day -1 (the day of OPD5 infusion)
Pharmacokinetics Cmax for OPD5 and the metabolites desethyl-melflufen and melphalan
Time frame: Day -1 (the day of OPD5 infusion)
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
Time frame: approximately Day 14
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
Time frame: approximately Day 14
Minimal Residual Disease (MRD) status by Next Generation sequencing (NGS) in patients that achieve a CR or VGPR.
Time frame: approximately Day 100
This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Oncopeptides AB