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

NCT04918511 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: OP-501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Relapse Multiple Myeloma; Multiple Myeloma

Outcome Measures

Primary Outcomes (12)

• 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

• Incidence of clinically significant changes in clinical laboratory parameters

  30 days post OPD5 treatment with ASCT

• Magnitude of clinically significant changes in clinical laboratory parameters

  30 days post OPD5 treatment with ASCT

• Incidence of clinically significant adverse findings in vital signs

  30 days post OPD5 treatment with ASCT

• Severity of clinically significant adverse findings in vital signs

  30 days post OPD5 treatment with ASCT

• Incidence of clinically significant adverse findings in electrocardiograms (ECGs)

  30 days post OPD5 treatment with ASCT

• Severity of clinically significant adverse findings in electrocardiograms (ECGs)

  30 days post OPD5 treatment with ASCT

• Incidence of clinically significant adverse findings in other physical examination parameters

  30 days post OPD5 treatment with ASCT

• Severity of clinically significant adverse findings in other physical examination parameters

  30 days post OPD5 treatment with ASCT

• Incidence of mucositis

  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)

  30 days post OPD5 treatment with ASCT

• The number of deaths not related to relapse or progression

  100 days post OPD5 treatment with ASCT

Secondary Outcomes (13)

• Best Response

  30 days post OPD5 treatment with ASCT

• Overall Response Rate (ORR)

  approximately 100 days post OPD5 treatment with ASCT

• Duration of response (DOR)

  approximately 12 months

• Time to progression (TTP)

  approximately 12 months

• Time to next treatment (TTNT)

  approximately 12 months

Study Arms (7)

Dose cohort 1

EXPERIMENTAL

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

Dose cohort 2

EXPERIMENTAL

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

Dose cohort 3

EXPERIMENTAL

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

Dose cohort 4

EXPERIMENTAL

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

Dose cohort 5

EXPERIMENTAL

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

Dose cohort 6

EXPERIMENTAL

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

Dose cohort 7

EXPERIMENTAL

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

Interventions

OPD5 DRUG

OPD5 solution for i.v. infusion

Dose cohort 1; Dose cohort 2; Dose cohort 3; Dose cohort 4; Dose cohort 5; Dose cohort 6; Dose cohort 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncopeptides AB: lead

Study Sites (3)

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

Brno, 62500, Czechia

Location

University Hospital Ostrava, Clinic of Hematooncology

Ostrava, Czechia

Location

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

Prague, Czechia

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sergio Giralt, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: May 27, 2021
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

CZ (3)