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4CPS-158 Relapsed/refractory multiple myeloma and new therapeutic options: experience in a phase 1 clinical trials unit
  1. A Martín Siguero1,
  2. C Donoso Rengifo1,
  3. E Laguna Ceba1,
  4. A Hernández Guío1,
  5. MG Daniel2,
  6. G Vega Achabal2,
  7. S Ramos Cillan2
  1. 1Hospital Universitario Fundación Jiménez Díaz, Start Phase I Unit Pharmacy, Madrid, Spain
  2. 2Hospital Universitario Fundación Jiménez Díaz, Start Phase I Unit Haematology, Madrid, Spain


Background and Importance Treatment landscape for relapsed/refractory Multiple Myeloma (RRMM) has changed significantly due to the availability and good results of new drugs such as immunotherapy agents.

Phase I clinical trials (CTs) allow patients to access new drugs prematurely, but the high complexity of these CTs makes essential the integration of a pharmacist in the Phase I team to ensure the safe preparation and dispensation of investigational drugs.

Aim and Objectives To know RRMM patient’s profile treated in a Phase I Unit, describe overall results in terms of efficacy and adverse effects, and analyse the pharmaceutical interventions (PIs) carried out and the medication-related problems (MRPs) detected.

Material and Methods Observational, retrospective study, with RRMM patients treated with investigational drugs in a Phase I CT Unit. Main data collected were demographics; number of previous treatment lines; ECOG at inclusion in CT; type of investigational treatment received; treatment effectiveness: type of response, overall survival (OS), progression-free survival (PFS); adverse effects (AEs); PIs and detection of MRPs.

Results 42 patients were analysed, average age was 67.6 years, 71.4% women, average previous lines 5, ECOG 1 and types of investigational treatments received were mostly Bispecific Antibody(Ab) (antiGPRC5D-CD3) +Bispecific Ab (antiBCMA-CD3) (26.2%) and Bispecific Ab (antiBCMA-CD3) + anti-CD38 Ab (26.2%).

54.8% of patients obtained partial or greater response. Median PFS was 11.5 months. Median OS was 25.3 months. 93% of patients experienced some AEs, most common were haematological, including neutropenia (29%), anaemia (21%), and platetopenia (12%).

36 PIs were carried out, mainly related to prescription errors (44%) and detection of drug interactions (33%). A PI was performed for each MRP detected, preventing negative results in all cases.

Conclusion and Relevance Patients with RRMM in Phase I CT Unit are middle-old age, highly pretreated and with acceptable functional status. Overall efficacy and safety results are positive, which reinforces participation in Phase I CT as an option to be evaluated.

The detection of prescription errors and drug interactions were high in number and with potential impact. Bispecific Abs seem to be a promising treatment for patients with RRMM and due to their complexity, the figure of the pharmacist proves to be essential within the healthcare team of Phase I CT Units.

Conflict of Interest No conflict of interest.

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