A study of the efficacy and safety of the combination of pomalidomide-bortezomib-low-dose dexamethasone comparted to just the combination of bortezomib-low-dose dexamethasone in subjects with multiple myeloma that have relapsed after treatment or that have not respnded to previous therapy

• Register: EUCTR
• Last refreshed on: 26 September 2023
• Main ID: EUCTR2014-000268-17-ES
• Date of registration: 03/03/2015
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: A study of the efficacy and safety of the combination of pomalidomide-bortezomib-low-dose dexamethasone comparted to just the combination of bortezomib-low-dose dexamethasone in subjects with multiple myeloma that have relapsed after treatment or that have not respnded to previous therapy
• Scientific title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA
• Date of first enrolment: 07/05/2015
• Target sample size: 782
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000268-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
1. Must be >= 18 years
2. Understand and voluntarily sign an informed consent document
3. Adhere to the study visit schedule and other protocol requirements.
4. Diagnosis of multiple myeloma and have measurable disease by serum or urine protein electrophoresis (sPEP or uPEP): sPEP >= 0.5 g/dL or uPEP >= 200 mg/24 hours.
5. At least 1 but no greater than 3 prior anti-myeloma regimens.
6. Documented disease progression during or after their last anti-myeloma therapy.
7. Must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles.
8. ECOG 0, 1, or 2.
9. Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 4 weeks before starting study treatment, while participating in the study (including dose interruptions), and for at least 4 weeks after study treatment discontinuation, and must agree to regular pregnancy testing during this timeframe.
10. Females must agree to abstain from breastfeeding during study participation and 4 weeks after study treatment discontinuation.
11. Males must agree to use a latex or synthetic condom
12. Males must also agree to refrain from donating sperm
13. All subjects must agree to refrain from donating blood
14. All subjects must agree not to share medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 352
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 430

Exclusion criteria:
1. Subjects who had documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule
2. Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization
3. Non-secretory multiple myeloma
4. Abnormal lab values (see protocol):
5. Subjects with severe renal impairment (Creatinine Clearance [CrCl] <30 mL/min) requiring dialysis
6. Subjects with prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years with the exception of the following non-invasive malignancies (see protocol)
7. Previous therapy with pomalidomide
8. History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, bortezomib, boron, mannitol, or dexamethasone
9. >= Grade 3 rash during prior thalidomide or lenalidomide therapy
10. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
11. Subjects with any one of the following (see protocolo)
12. Subjects who received any of the following within the last 14 days of initiation of study treatment (see protocol)
13. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
See protocol for the rest of exclusion criteria


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

relapsed or refractory multiple myeloma (MM)
MedDRA version: 17.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Imnovid 1 mg cápsulas duras
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pomalidomida
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Other descriptive name: POMALIDOMIDA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Imnovid 2 mg cápsulas duras
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pomalidomida
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Other descriptive name: POMALIDOMIDA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: Imnovid 3 mg cápsulas duras
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pomalidomida
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Other descriptive name: POMALIDOMIDA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Trade Name: Imnovid 4 mg cápsulas duras
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pomalidomida
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Other descriptive name: POMALIDOMIDA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Trade Name: Velcade
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-

Trade Name: Dexamethasone Tablets BP 2.0 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETASONA
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: Dexamethason-ratiopharm® 4 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETASONA
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:

Primary Outcome(s)

Secondary Objective: To evaluate the safety and additional efficacy of POM + BTZ + LD-DEX versus BTZ + LD-DEX in subjects with relapsed or refractory MM.

Timepoint(s) of evaluation of this end point: PFS will be assessed by:
- Bone Marrow Aspiration and/or Biospy ? Screening and as Clinically indicated or to confirm CR
- Quantitative Serum Immunoglobulins, serum-protein electrophoresis (sPEP), 24-hour urine protein electrophoresis, serum and urine immunofixation, serum free light-chain assay, and extramedullary plasmacytoma (EMPs) at Screening and Day 1 of each cycle and PFS Follow-up (if applicable). If EMPs are only assessable radiographically, scans are to be conducted at Screening, C3D1, every 3 cycles thereafter during treatment, at treatment discontinuation, every 63 days (3 cycles) during the PFS follow-up phase, at PFS follow-up phase discontinuation, and when clinically indicated to confirm response (> or = PR)
-Skeletal Surveys ? Screening and when clinically indicated

Main Objective: To compare the efficacy of POM + BTZ + LD-DEX with BTZ + LD-DEX in subjects with relapsed or refractory MM

Primary end point(s): Progression-Free Survival (PFS)

Secondary Outcome(s)

Secondary end point(s): -Overall Survival (OS)
-Safety (type, frequency, seriousness and severity of AEs, and relationship of AEs to study drug or comparator)
-Overall response rate (ORR) (using the International Myeloma Working Group Uniform [IMWG] response criteria)
-Duration of response

Timepoint(s) of evaluation of this end point: OS: All long-term follow-up phase subjects will be contacted four (4) times a year (every 3 months) to obtain survival status for at least 5 years after the last subject is randomized into the study, or longer if clinically indicated
Safety: i. AEs: After signing ICF and until 28 days after treatment discontinuation; ii. SPM: After signing ICF up to and including the long-term follow-up period and up to 5 years after last subject enrolled
Overall Response Rate (ORR): when assessable
Duration of Response: when assessable

Secondary ID(s)

CC-4047-MM-007

2014-000268-17-IE

NCT01734928

Source(s) of Monetary Support

Celgene Corporation

Ethics review

Status: Approved
Approval date: 13/04/2015
Contact:

Results

• Results available: Yes
• Date Posted: 25/05/2023
• Date Completed: 13/05/2022
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000268-17/results