Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients

Phase 1/2 Terminated 75 enrolled Oncopeptides AB

Non-randomizedSequentialOpen-labelTreatment

Summary

The study will explore escalating doses of melflufen in combination with dexamethasone in small groups of patients to find the maximum tolerated dose of melflufen. That dose will then be used to determine the efficacy and safety profile of melflufen in combination with dexamethasone in a larger group of patients.

Timeline

Start: 2013-07
Primary completion: 2017-12
Completion: 2020-03

Outcome

Outcome not reported

Stopped: “The study was terminated at median 46-48 months long term follow-up and mature overall survival follow-up data.”

Publications

Richardson PG, Bringhen S, Voorhees P, Plesner T, Mellqvist UH, Reeves B, Paba-Prada C, Zubair H, Byrne C, Chauhan D, Anderson K, Nordstrom E, Harmenberg J, Palumbo A, Sonneveld P. Melflufen plus dexamethasone in relapsed and refractory multiple myeloma (O-12-M1): a multicentre, international, open-label, phase 1-2 study. Lancet Haematol. 2020 May;7(5):e395-e407. doi: 10.1016/S2352-3026(20)30044-2. Epub 2020 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Melphalan flufenamide	Peptide	15 mg	Intravenous
Subject	Melphalan flufenamide	Peptide	25 mg	Intravenous
Subject	Melphalan flufenamide	Peptide	40 mg	Intravenous
Subject	Melphalan flufenamide	Peptide	55 mg	Intravenous
Background	Dexamethasone	Small molecule	40 mg	Oral