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Corticosteroid

Melflufen for Multiple Myeloma (OCEAN Trial)

Q: What does the scientific community know about Melflufen?

<p>Melflufen was first studied in 2002 at Manitoba Blood &#x26; Marrow <a href="https://www.withpower.com/clinical-trials/transplant">Transplant</a> Program CancerCare Manitoba. In the 18 years since then, there have been 1134 completed clinical trials with 594 currently active trials. A large number of these studies are based in <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>.</p>

Phase 3

Waitlist Available

Led By Pieter Sonneveld, Prof.

Research Sponsored by Oncopeptides AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause, up to the data cutoff date of 03 feb 2021 (ie, assessed up to approximately 43 months).

Awards & highlights

OCEAN Trial Summary

This trial will compare the effectiveness of two different drugs for patients with RRMM who have failed prior treatment with lenalidomide.

Eligible Conditions

Multiple Myeloma

OCEAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 feb 2021 (ie, assessed up to approx. 43 months). median time to best response: arm a=2.1 months and arm b=2.0 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 feb 2021 (ie, assessed up to approx. 43 months). median time to best response: arm a=2.1 months and arm b=2.0 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 feb 2021 (ie, assessed up to approx. 43 months). median time to best response: arm a=2.1 months and arm b=2.0 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

Duration of Response (DOR)

Overall Response Rate (ORR)

Overall Survival (OS)

+1 more

OCEAN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: Melflufen+DexamethasoneExperimental Treatment2 Interventions

Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.

Group II: Arm B: Pomalidomide+DexamethasoneActive Control2 Interventions

Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oncopeptides ABLead Sponsor

9 Previous Clinical Trials

410 Total Patients Enrolled

7 Trials studying Multiple Myeloma

377 Patients Enrolled for Multiple Myeloma

Pieter Sonneveld, Prof.Principal InvestigatorErasmus Medical Center

1 Previous Clinical Trials

1,503 Total Patients Enrolled

1 Trials studying Multiple Myeloma

1,503 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the scientific community know about Melflufen?

"Melflufen was first studied in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. In the 18 years since then, there have been 1134 completed clinical trials with 594 currently active trials. A large number of these studies are based in Kansas City, Missouri."

Answered by AI

What are the FDA's thoughts on Melflufen?

"Melflufen's safety is commonly cited as a 3 because there is available evidence from Phase 3 trials to support both efficacy and safety."

Answered by AI

What are the most popular indications for Melflufen?

"Melflufen is most often used to treat ophthalmia, sympathetic. However, it has also been used as a treatment for other conditions such as branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

Are there a lot of places in town where I can participate in this research?

"Currently, 18 hospitals are enrolling patients for this study. They are situated in cities such as Kansas City, Dallas, Canton and 16 other locations. If you enroll, try and select a hospital close to your residence to reduce travel."

Answered by AI

Are there any vacancies in this clinical trial for new participants?

"This study, which was first posted on 2017-06-12 and last updated on 2022-09-19, as indicated on clinicaltrials.gov, is not currently looking for new study participants. Although, there are 1,420 other trials actively recruiting patients."

Answered by AI

How many subjects are enrolled in this trial?

"This study is no longer recruiting patients. The study was first posted on 2017-06-12 and was most recently edited on 2022-09-19. If you are searching for other studies, 826 clinical trials for multiple myeloma and 594 studies for Melflufen are currently recruiting patients."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Melflufen or Pomalidomide Plus Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide (OCEAN): A Randomised, Head-to-head, Open-label, Phase 3 Study

Schjesvold, Fredrik H, Meletios-Athanasios Dimopoulos, Sosana Delimpasi, Pawel Robak, Daniel Coriu, Wojciech Legiec, Luděk Pour, et al.. 2022. “Melflufen or Pomalidomide Plus Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide (OCEAN): A Randomised, Head-to-head, Open-label, Phase 3 Study”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(21)00381-1.

The Lancet HaematologyJournal

Melflufen or Pomalidomide Plus Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide (OCEAN): A Randomised, Head-to-head, Open-label, Phase 3 Study

clinicaltrials.govStudy

A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide

2017. "A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03151811.