Trial record 1 of 1 for:    CC-4047-MM-007
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Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (OPTIMISMM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01734928
First received: November 23, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to compare the efficacy of the combination of Pomalidomide, Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of Bortezomib and Dexamethasone


Condition Intervention Phase
Multiple Myeloma
Drug: Pomalidomide
Drug: Bortezomib
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The length of time during and after the treatment that participants in the study live without the disease getting worse


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The length of time from start of study treatment that participants in the study are alive

  • Adverse Event [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Overall Response Rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The percentage of participants who respond to study treatment

  • Duration of Response [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The length of time from when participants respond to the study treatment to when their disease gets worse


Estimated Enrollment: 782
Study Start Date: December 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomalidomide, Bortezomib and Low Dose Dexamethasone
4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered intravenously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.
Drug: Pomalidomide
Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
Other Names:
  • Oral Pomalidomide
  • CC-4047
Drug: Bortezomib
Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
Other Name: Velcade
Drug: Dexamethasone
Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
Active Comparator: Bortezomib and Low Dose Dexamethasone
1.3 mg/m2 of Bortezomib will be administered intravenously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day [≤ 75 years old]or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
Drug: Bortezomib
Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
Other Name: Velcade
Drug: Dexamethasone
Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be ≥ 18yrs 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:

  • Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734928

Contacts
Contact: Deborah Ingenito 908-673-9581 dingenito@celgene.com

  Show 52 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Ye Hua, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01734928     History of Changes
Other Study ID Numbers: CC-4047-MM-007
Study First Received: November 23, 2012
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Multiple Myeloma
Pomalidomide

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 22, 2014