Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma

NCT04287855 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: IsKPd - IFM2018-03
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma. Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Outcome Measures

Primary Outcomes (1)

• Efficacy of trial treatment

  Fraction of patients who experience a Minimal Residual Disease (MRD) 10-5 per IMWG (International Myeloma Working Group) criteria

  Up to 5 years

Secondary Outcomes (3)

• Safety of trial treatment

  Up to 5 years

• Depth of response to the trial treatment

  Up to 5 years

• Progression Free survival

  Up to 5 years

Study Arms (1)

Intervention

EXPERIMENTAL

Isatuximab, Carfilzomib, Pomalidomide and Dexamethasone

Drug: Isatuximab; Drug: Carfilzomib; Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Isatuximab DRUG

Isatuximab by IV route - Cycle 1 : 10mg/kg on days 1, 8, 15 and 22 per 28 days cycle. After cycle 1 : 10mg/kg on days 1 and 15 per 28 days cycle

Intervention

Carfilzomib DRUG

Carfilzomib by IV route - Cycle 1 : 20/27 mg/m² on days 1-2, 8-9, 15-16 per 28 days cycle. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.

Intervention

Pomalidomide DRUG

Pomalidomide by oral route - Cycle 1-2 : 3mg on days 1 to 21 per 28 days cycle. After cycle 2 : 4mg on days 1 to 21 per 28 days cycle.

Intervention

Dexamethasone DRUG

Dexamethasone by oral route - Cycle 1-13 : 40/20 mg on days 1, 8, 15 and 22. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to understand and voluntarily sign an informed consent form
• Must be able to adhere to the study visit schedule and other protocol requirements
• Male or female, age 18 years or older
• Life expectancy of \> 6 months.
• Must have a in R1 and R2 relapse Multiple Myeloma with a measurable disease :
• to maximum 2 lines of therapy prior to study entry
• Relapse Refractory or primary refractory or relapse
• Must have received prior treatment with a Lenalidomide-containing regimen for at least 2 consecutive cycles
• Must have measurable disease as defined by the following: must have a clearly detectable and quantifiable monoclonal M-component value in the serum and/or urine :
• IgG/IgA (serum M-component \> 5g/l),
• Light chain (serum M-component \>1g/l or Bence Jones \> 200mg/24H),
• Serum FLC assay (including for IgD isotypes): involved FLC level \> 10 mg/dl provided serum.
• FLC ratio is abnormal for patients not measurable on any of the 3 above criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

You may not qualify if:

• Adequate bone marrow function, documented within 72 hours and without transfusion 72 hours prior to the first intake of investigational product (C1J1) with no growth factor support (one week), defined as :
• Absolute neutrophils ≥ 1 x109/L,
• Untransfused Platelet count ≥ 75 x109/L,
• Hemoglobin ≥ 8.5 g/dL.
• Adequate organ function defined as :
• Serum total bilirubin \< 2x upper limit of normal (ULN),
• Clearance creatinine ≥ 30ml/min,
• Serum SGOT/AST or SGPT/ALT \< 3x upper limit of normal (ULN).
• Patients affiliated to an appropriate social security system.
• A man who is sexually active with a pregnant female or a FCBP\* must agree to use a barrier method of birth control eg, condom with spermicidal foam/gel/film/cream/suppository, even if he has had a vasectomy. All men must also not donate sperm, spermatozoa during the study, for 5 months following treatment discontinuation.
• A woman FCBP\* must understand and agree to use 2 reliable effective methods (a very effective method and an effective additional method) of contraception simultaneously without interruption :
• For at least 28 days before starting experimental treatments,
• Throughout the entire duration of experimental treatments,
• During dose interruptions,
• And for at least 5 months after the last dose of experimental treatments.

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Sanofi: collaborator
• Celgene: collaborator
• Amgen: collaborator
• Intergroupe Francophone du Myelome: collaborator

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab; carfilzomib; pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• LELEU Xavier, Prof.

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 27, 2020
• Study Start: August 28, 2020
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2026
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

FR (1)