Alternate Day Dosing of Pomalidomide in Patients With Refractory Multiple Myeloma

NCT03520985 | Terminated Phase 2 DMC

• 1 other identifier: SAKK 39/16 - OptiPOM
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 16

Brief Summary

Pomalidomide is an approved treatment for refractory multiple myeloma. Toxicity of pomalidomide in the pivotal MM-003 trial, was considerable, with 60% of patients experiencing drug-related G3/4 toxicity. Neutropenia (48% vs 16%) and pneumonia (13% vs 8%) were significantly more common in the pomalidomide arm. This resulted in frequent dose interruptions (67%) and dose reductions (27%). This suggests that for the majority of patients the 4 mg daily dosing schedule is too toxic, and that strategies to deliver reduced dosing of pomalidomide are of high practical relevance. The aim of this trial therefore is to establish that alternate day dosing of pomalidomide (4 mg q2d, d1-28) is non-inferior to daily dosing (4 mg d1-21 q28) in terms of efficacy of the drug with potentially less side effects.

Conditions

Refractory Multiple Myeloma

Keywords

refractory Multiple Myeloma; Phase II; Pomalidomide; OptiPOM

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  OR is defined as minimal response or better, assessed according to the IMWG criteria.

  From date of registration until 28 days after last dose of trial medication with longest treatment time of approximately 36 months

Secondary Outcomes (3)

• Overall Survival (OS)

  From date of registration until 28 days after last dose of trial medication with longest treatment time of approximately 36 months

• Overall Survival (OS) at 12 months

  at 12 months

• Progression-free survival (PFS)

  From date of registration until 28 days after last dose of trial medication with longest treatment time of approximately 36 months

Study Arms (1)

Pomalidomide

EXPERIMENTAL

The treatment in this trial consists of oral pomalidomide on alternate days (ad) plus Low-Dose Dexamethasone (adPOM + LD-DEX)

Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Pomalidomide DRUG

Pomalidomide (4 mg p.o.) will be administered on every other day of each 28-day treatment cycle. Treatment duration: Treatment cycles are repeated until confirmed disease progression.

Also known as: Imnovid®

Pomalidomide

Dexamethasone DRUG

For patients ≤ 75 years of age: Low-Dose Dexamethasone (40 mg p.o.) will be administered once per day on days 1, 7, 15, and 21 of a 28-day cycle. For patients \> 75 years of age: Low-Dose Dexamethasone (20 mg p.o.) will be administered once per day on days 1, 7, 15, and 21 of a 28-day cycle. Treatment duration: Treatment cycles are repeated until confirmed disease progression.

Pomalidomide

Eligibility Criteria

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

You may qualify if:

• Patient was diagnosed with multiple myeloma based on standard IMWG criteria
• Prior treatment with ≥ 2 treatment lines of anti-myeloma therapy
• Patients must have been exposed to both lenalidomide and bortezomib
• Measurable disease for myeloma defined as one of the following: serum M-protein ≥ 5 g/L; urine M-protein ≥ 0.2 g/24 hours
• Refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy.
• Adequate hematological and hepatic function

You may not qualify if:

• History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration, with the exception of pT1-2 prostate cancer Gleason score ≤6, adequately treated, cervical carcinoma in situ or localized non-melanoma skin cancer.
• Polyneuropathy grade \> 2
• Patients who received any of the following within the last 14 days of initiation of trial treatment:
• Plasmapheresis
• Major surgery (kyphoplasty is not considered major surgery)
• Radiation therapy
• Use of any anti-myeloma drug therapy
• Known or clinically suspected myeloma manifestations in the central nervous system
• Severe or uncontrolled cardiovascular disease

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (16)

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden (Baden/Brugg)

Baden, 5404, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Istituto Oncologico Svizzera Italiana IOSI

Bellinzona, 6500, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Kantonsspital Graubünden

Chur, CH-7000, Switzerland

Location

Hopital Fribourgeois HFR

Fribourg, 1708, Switzerland

Location

Kantonsspital Liestal

Liestal, CH-4410, Switzerland

Location

Kantonsspital Luzern

Luzerne, CH-6000, Switzerland

Location

Spital Thurgau AG

Münsterlingen, 8596, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Regionalspital Thun

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Onkozentrum Hirslanden Zürich

Zurich, 8032, Switzerland

Location

OnkoZentrum Zürich AG - Klinik im Park

Zurich, 8038, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

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

• Thilo Zander, MD

  Luzerner Kantonsspital

  STUDY CHAIR

• Christoph Driessen, Prof

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

• Christoph Renner, Prof

  Onkozentrum Zürich

  STUDY CHAIR

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: April 17, 2018
• First Posted: May 11, 2018
• Study Start: October 1, 2018
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

CH (16)