Trial Outcomes & Findings for Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma (NCT NCT00458705)

Last Updated: 2016-01-22

Results Overview

The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

2 years

Results posted on

2016-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Combination Therapy Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
Overall Study STARTED	45
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Therapy Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
Overall Study Adverse Event	4
Overall Study Not Treated	1

Baseline Characteristics

Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Therapy n=45 Participants Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Combination Therapy n=40 Participants Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
Disease Response Complete Response	10 participants
Disease Response Near Complete Response	8 participants
Disease Response Partial Response	10 participants
Disease Response Stable Disease	2 participants
Disease Response Progression of Disease	3 participants
Disease Response Very Good Partial Response	7 participants

Adverse Events

Combination Therapy

Serious events: 22 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Therapy n=45 participants at risk Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
Metabolism and nutrition disorders Acidosis	2.2% 1/45 • Number of events 1
Cardiac disorders Atrial fibrillation	2.2% 1/45 • Number of events 1
Metabolism and nutrition disorders Hypocalcemia	2.2% 1/45 • Number of events 1
Gastrointestinal disorders Constipation	4.4% 2/45 • Number of events 2
Investigations Creatinine increased	2.2% 1/45 • Number of events 1
General disorders Death not assoc w CTCAE term- Multi-organ failure	2.2% 1/45 • Number of events 1
Metabolism and nutrition disorders Dehydration	2.2% 1/45 • Number of events 1
Gastrointestinal disorders Diarrhea	4.4% 2/45 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 3/45 • Number of events 5
General disorders Fever	2.2% 1/45 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	6.7% 3/45 • Number of events 3
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.2% 1/45 • Number of events 1
Hepatobiliary disorders Hepatobiliary disorders -other, specify	2.2% 1/45 • Number of events 1
Vascular disorders Hypotension	2.2% 1/45 • Number of events 1
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 1/45 • Number of events 1
Infections and infestations Sepsis	2.2% 1/45 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	6.7% 3/45 • Number of events 3
Infections and infestations Infection	6.7% 3/45 • Number of events 3
Hepatobiliary disorders Hepatic failure	2.2% 1/45 • Number of events 1
Investigations Lymphocyte count decrease	2.2% 1/45 • Number of events 1
Nervous system disorders Peripheral sensory neuropathy	2.2% 1/45 • Number of events 1
Gastrointestinal disorders Abdominal pain	2.2% 1/45 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	4.4% 2/45 • Number of events 2
Nervous system disorders Neuralgia	2.2% 1/45 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/45 • Number of events 1
Metabolism and nutrition disorders Hyperkalemia	2.2% 1/45 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders-other, specify	2.2% 1/45 • Number of events 1
Renal and urinary disorders Renal and urinary disorders -other, specify, Renal failure	11.1% 5/45 • Number of events 5
Metabolism and nutrition disorders Hyponatremia	2.2% 1/45 • Number of events 1
Vascular disorders Thrombosis/thrombus/embolism	13.3% 6/45 • Number of events 7
Renal and urinary disorders Urinary retention	2.2% 1/45 • Number of events 1
Nervous system disorders Vasovagal reaction	2.2% 1/45 • Number of events 1

Other adverse events

Other adverse events
Measure	Combination Therapy n=45 participants at risk Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
Gastrointestinal disorders Constipation	11.1% 5/45 • Number of events 5
Gastrointestinal disorders Diarrhea	8.9% 4/45 • Number of events 4
Respiratory, thoracic and mediastinal disorders Pneumonia	6.7% 3/45 • Number of events 3
Nervous system disorders Peripheral sensory neuropathy	8.9% 4/45 • Number of events 6
Musculoskeletal and connective tissue disorders Back pain	6.7% 3/45 • Number of events 3
Nervous system disorders Neuralgia	8.9% 4/45 • Number of events 6
Renal and urinary disorders Renal and urinary disorders -other, specify-Renal failure	8.9% 4/45 • Number of events 4
Vascular disorders Thrombosis/thrombus/embolism	17.8% 8/45 • Number of events 11

Additional Information

Dr. Heather Landau

Memorial Sloan Kettering Cancer Center

Phone: 212-639-8808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place