Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2023
• Main ID: NCT01734928
• Date of registration: 23/11/2012
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma OPTIMISMM
• 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: January 7, 2013
• Target sample size: 559
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01734928
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Sweden, Turkey, United Kingdom, United States

Contacts

• Name: Amine Bensmaine, MD
• Affiliation: Celgene Corporation

• Name: Bristol Myers-Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must be = 18 years at the time of signing informed consent.

- Must have documented diagnosis of multiple myeloma and have measureable disease by
serum and urine protein electrophoresis.

- Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.

- Must have documented disease progression during or after their last anti-myeloma
therapy.

- All subjects must have received prior treatment with a lenalidomide containing regimen
for at least 2 consecutive cycles.

Exclusion Criteria:

- Documented progressive disease during therapy or within 60 days of the last dose of a
bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.

- Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to
randomization.

- Non-secretory multiple myeloma.

- Subjects with severe renal impairment requiring dialysis.

- Previous therapy with pomalidomide.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: Dexamethasone

Drug: Pomalidomide

Drug: Bortezomib

Primary Outcome(s)

Progression Free Survival by Independent Response Adjudication Committee (IRAC) [Time Frame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months]

Secondary Outcome(s)

Overall Survival (OS) [Time Frame: From randomization to date of death, up to approximately 65 months]

Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE) [Time Frame: From first dose to 28 days after the last dose (up to approximately 44 months]

Overall Response Rate by Independent Response Adjudication Committee (IRAC) [Time Frame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months]

Duration of Response by Independent Response Adjudication Committee (IRAC) [Time Frame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months]

Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE) [Time Frame: From first dose to 28 days after the last dose (up to approximately 44 months]

Secondary ID(s)

CC-4047-MM-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/06/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01734928