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Relapse Multiple MyelomaPhase 1COASTNCT04918511

A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma

A Phase 1 study testing OPD5 in people with Relapse Multiple Myeloma and Multiple Myeloma, run by Oncopeptides AB at 3 sites in Czechia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapse Multiple Myeloma, Multiple Myeloma
What is being tested?
OPD5
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesCzechia
Study dates
27 May 2021to Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Czechia3 sites

  • University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology

    Brno, 62500

  • University Hospital Ostrava, Clinic of Hematooncology

    Ostrava

  • Charles University and General Hospital in Prague, 1st Department of Medicine - Department of Hematology, First Faculty of Medicine

    Prague

Other trials in Czechia

About this study

Official title: An Open-label Phase I, Dose Escalation Study of the Safety and Tolerability of OPD5 as Myeloablative Conditioning Regimen Followed by Autologous Stem Cell Transplant (ASCT) for Patients With Relapsed Refractory Multiple Myeloma (RRMM)

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.

Being tested
OPD5
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPD5Drug

    OPD5 solution for i.v. infusion

Study groups in NCT04918511
Study groupRoleWhat they receive
Dose cohort 1ExperimentalIn 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)
Receives: Drug: OPD5
Dose cohort 2ExperimentalIn 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
Receives: Drug: OPD5
Dose cohort 3ExperimentalIn 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
Receives: Drug: OPD5
Dose cohort 4ExperimentalIn 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
Receives: Drug: OPD5
Dose cohort 5ExperimentalIn 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
Receives: Drug: OPD5
Dose cohort 6ExperimentalIn 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
Receives: Drug: OPD5
Dose cohort 7ExperimentalIn 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
Receives: Drug: OPD5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and grade of Treatment Emergent Adverse Events (TEAEs)

    Including frequency and grade of defined Dose Limiting Toxicities

    Measured: 30 days post OPD5 treatment with ASCT

  2. Incidence of clinically significant changes in clinical laboratory parameters

    Measured: 30 days post OPD5 treatment with ASCT

  3. Magnitude of clinically significant changes in clinical laboratory parameters

    Measured: 30 days post OPD5 treatment with ASCT

  4. Incidence of clinically significant adverse findings in vital signs

    Measured: 30 days post OPD5 treatment with ASCT

  5. Severity of clinically significant adverse findings in vital signs

    Measured: 30 days post OPD5 treatment with ASCT

  6. Incidence of clinically significant adverse findings in electrocardiograms (ECGs)

    Measured: 30 days post OPD5 treatment with ASCT

  7. Severity of clinically significant adverse findings in electrocardiograms (ECGs)

    Measured: 30 days post OPD5 treatment with ASCT

  8. Incidence of clinically significant adverse findings in other physical examination parameters

    Measured: 30 days post OPD5 treatment with ASCT

  9. Severity of clinically significant adverse findings in other physical examination parameters

    Measured: 30 days post OPD5 treatment with ASCT

  10. Incidence of mucositis

    Measured: 30 days post OPD5 treatment with ASCT

  11. Severity of mucositis

    Using World Health Organization (WHO) oral toxicity scale, from 0 (no change) to 4 (oral feeding is not possible)

    Measured: 30 days post OPD5 treatment with ASCT

  12. The number of deaths not related to relapse or progression

    Measured: 100 days post OPD5 treatment with ASCT

Secondary outcomes (13)

  1. 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)

    Measured: 30 days post OPD5 treatment with ASCT

  2. Overall Response Rate (ORR)

    Proportion of patients who achieve response of CR, sCR, VGPR or PR as their best response.

    Measured: approximately 100 days post OPD5 treatment with ASCT

  3. 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

    Measured: approximately 12 months

  4. Time to progression (TTP)

    Time from the date of OPD5 administration to the date of the first documented confirmed PD

    Measured: approximately 12 months

  5. 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)

    Measured: approximately 12 months

  6. 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

    Measured: approximately 12 months

  7. Pharmacokinetics Area under the curve AUC(0-t) for OPD5 and the metabolites desethyl-melflufen and melphalan

    Measured: Day -1 (the day of OPD5 infusion)

  8. Pharmacokinetics AUC(0-infinity) for OPD5 and the metabolites desethyl-melflufen and melphalan

    Measured: Day -1 (the day of OPD5 infusion)

  9. Pharmacokinetics elimination half-life (t½) for OPD5 and the metabolites desethyl-melflufen and melphalan

    Measured: Day -1 (the day of OPD5 infusion)

  10. Pharmacokinetics Cmax for OPD5 and the metabolites desethyl-melflufen and melphalan

    Measured: Day -1 (the day of OPD5 infusion)

  11. 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

    Measured: approximately Day 14

  12. 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

    Measured: approximately Day 14

  13. Minimal Residual Disease (MRD) status by Next Generation sequencing (NGS) in patients that achieve a CR or VGPR.

    Measured: approximately Day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start27 May 2021 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: Sponsor made the decision to terminate the COAST study to refocus the OPD5 clinical program.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
A minimum of 3 and up to 6 evaluable patients will be enrolled per dose level. After the first cohort, the doses for the following dose cohorts will be adaptively escalated/de-escalated based on observed dose limiting toxicities in previous cohort.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918511
Sponsor's protocol ID
OP-501
Acronym
COAST
Status last verified
Nov 2021
First submitted
27 May 2021
Last updated
26 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OPD5 in people with Relapse Multiple Myeloma and Multiple Myeloma, run by Oncopeptides AB at 3 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and grade of Treatment Emergent Adverse Events (TEAEs) (time frame: 30 days post OPD5 treatment with ASCT). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04918511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.

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