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

Oncopeptides

Status and phase: Withdrawn; Phase 1

Conditions: Multiple Myeloma; Relapse Multiple Myeloma

Treatments: Drug: OPD5

Study type: Interventional

Funder types: Industry

Identifiers

NCT04918511

OP-501

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

0 participants in 7 patient groups

Dose cohort 1

Experimental group

Description:

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)

Treatment:

Drug: OPD5

Dose cohort 2

Experimental group

Description:

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

Treatment:

Drug: OPD5

Dose cohort 3

Experimental group

Description:

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

Treatment:

Drug: OPD5

Dose cohort 4

Experimental group

Description:

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

Treatment:

Drug: OPD5

Dose cohort 5

Experimental group

Description:

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

Treatment:

Drug: OPD5

Dose cohort 6

Experimental group

Description:

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

Treatment:

Drug: OPD5

Dose cohort 7

Experimental group

Description:

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

Treatment:

Drug: OPD5