Trial record 1 of 2 for:
sEAPort
Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma (sEAPort)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04534322 |
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Expanded Access Status :
Available
First Posted : September 1, 2020
Last Update Posted : March 1, 2021
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Sponsor:
Oncopeptides AB
Information provided by (Responsible Party):
Oncopeptides AB
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| Tracking Information | |||||||||
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| First Submitted Date | August 26, 2020 | ||||||||
| First Posted Date | September 1, 2020 | ||||||||
| Last Update Posted Date | March 1, 2021 | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma | ||||||||
| Brief Summary | To provide early treatment access and evaluate the safety of melflufen and dexamethasone in patients with triple class refractory (TCR) multiple myeloma (MM). | ||||||||
| Detailed Description | This is a multicenter, expanded access program protocol to provide access to melflufen for patients with RRMM in medical need, who have progressive disease after they received a minimum of at least two prior lines of therapy, are triple-class refractory to at least one PI, at least one IMiD and at least one anti-CD38 mAb or intolerant to a specific therapeutic drug class. Patients with primary refractory MM are eligible to participate as long as they meet the criteria of being triple class refractory. They may meet these criteria for triple class refractory MM if they have received at least one PI, at least one IMiD, and at least one Anti-CD38 mAb in their first line treatment or have had at least 2 prior lines of therapy. | ||||||||
| Study Type | Expanded Access | ||||||||
| Expanded Access Type | Intermediate-size Population, Treatment IND/Protocol | ||||||||
| Intervention |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Expanded Access Status | Available | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04534322 | ||||||||
| Responsible Party | Oncopeptides AB | ||||||||
| Study Sponsor | Oncopeptides AB | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Oncopeptides AB | ||||||||
| Verification Date | February 2021 | ||||||||