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

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:

Genetics Home Reference related topics: multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Pomalidomide Dexamethasone acetate Bortezomib

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

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:	544
Study Start Date:	January 2013
Estimated Study Completion Date:	April 2022
Estimated Primary Completion Date:	May 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.

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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: Eva Budz	908-897-4325	ebudz@celgene.com
Contact: Phyllis Whalen	908-897-4385	pwhalen@celgene.com

Show 196 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators


Study Director:	Amine Bensmaine, MD	Celgene Corporation

More Information


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:	September 14, 2016
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 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

ClinicalTrials.gov processed this record on September 27, 2016

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