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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734928
First Posted: November 28, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  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
Intervention Model: Parallel Assignment
Masking: None (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:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 1 year ]
    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 ]
    The length of time from start of study treatment that participants in the study are alive

  • Adverse Event [ Time Frame: Up to 1 year ]
    Number of participants with adverse events

  • Overall Response Rate [ Time Frame: Up to 1 year ]
    The percentage of participants who respond to study treatment

  • Duration of Response [ Time Frame: Up to 1 year ]
    The length of time from when participants respond to the study treatment to when their disease gets worse


Enrollment: 559
Actual Study Start Date: January 7, 2013
Estimated Study Completion Date: April 24, 2022
Estimated Primary Completion Date: May 30, 2018 (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 subcutaneously 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 subcutaneously 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 subcutaneously 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 subcutaneously 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734928


  Show 198 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Amine Bensmaine, MD Celgene Corporation
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01734928     History of Changes
Other Study ID Numbers: CC-4047-MM-007
First Submitted: November 23, 2012
First Posted: November 28, 2012
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by Celgene:
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
Pomalidomide
Bortezomib
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal