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NCT04918511

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

NCT ID: NCT04918511

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapse Multiple Myeloma Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose cohort 1

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)

Group Type EXPERIMENTAL

OPD5

Intervention Type DRUG

OPD5 solution for i.v. infusion

Dose cohort 2

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

Group Type EXPERIMENTAL

OPD5

Intervention Type DRUG

OPD5 solution for i.v. infusion

Dose cohort 3

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

Group Type EXPERIMENTAL

OPD5

Intervention Type DRUG

OPD5 solution for i.v. infusion

Dose cohort 4

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

Group Type EXPERIMENTAL

OPD5

Intervention Type DRUG

OPD5 solution for i.v. infusion

Dose cohort 5

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

Group Type EXPERIMENTAL

OPD5

Intervention Type DRUG

OPD5 solution for i.v. infusion

Dose cohort 6

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

Group Type EXPERIMENTAL

OPD5

Intervention Type DRUG

OPD5 solution for i.v. infusion

Dose cohort 7

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

Group Type EXPERIMENTAL

OPD5

Intervention Type DRUG

OPD5 solution for i.v. infusion

Interventions

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OPD5

OPD5 solution for i.v. infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oncopeptides AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergio Giralt, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Centre, New York City, United States

Locations

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

Brno, , Czechia

Site Status

University Hospital Ostrava, Clinic of Hematooncology

Ostrava, , Czechia

Site Status

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

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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OP-501

Identifier Type: -

Identifier Source: org_study_id