Trial Outcomes & Findings for Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma (NCT NCT00378209)

Last Updated: 2016-11-17

Results Overview

Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: \>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) \>25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) \>25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture). Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

6 months after therapy

Results posted on

2016-11-17

Participant Flow

65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment.

Participants screened over a 3 week period.

Participant milestones

Participant milestones
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Overall Study STARTED	64
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Overall Study Progressive disease	11
Overall Study Adverse Event	3
Overall Study Initiation of non-protocol therapy	3
Overall Study Physician Decision	3
Overall Study Death	1
Overall Study Treatment delay	1

Baseline Characteristics

Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 Participants Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after therapy

Outcome measures

Outcome measures
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 Participants Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months	75 percentage of treated patients Interval 65.0 to 84.0

SECONDARY outcome

Timeframe: Assessed every cycle for up to 8 cycles and best response was reported

Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response).

Outcome measures

Outcome measures
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 Participants Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Objective Response Rate	64 percentage of treated patients Interval 53.0 to 74.0

SECONDARY outcome

Timeframe: Assessed at a median follow-up of 44 months

Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.

Outcome measures

Outcome measures
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 Participants Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Duration of Response	8.7 months Interval 6.6 to 11.1

SECONDARY outcome

Timeframe: aassesed at a median follow-up of 44 months

Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.

Outcome measures

Outcome measures
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 Participants Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Progression Free Survival	9.5 months Interval 7.2 to 11.7

SECONDARY outcome

Timeframe: assesed at a median follow-up of 44 months

defined as time from treatment initiation to death, or last known to be alive for those who had not died

Outcome measures

Outcome measures
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 Participants Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Overall Survival	30 month Interval 24.0 to 37.0

Adverse Events

Lenalidomide, Dexamethasone, Bortezomib Combination

Serious events: 47 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 participants at risk Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
General disorders Fatigue	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Neutropenia	29.7% 19/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Gastrointestinal disorders Diarrhea	3.1% 2/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders hyperglycemia	9.4% 6/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders peripheral edema	3.1% 2/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Thrombocytopenia	21.9% 14/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Pain: extremity	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Anemia	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Leukopenia	9.4% 6/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Nervous system disorders Motor Neuropathy	3.1% 2/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders rash/desquamation	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Dizziness	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Lymphopenia	10.9% 7/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders Hyponatremia	7.8% 5/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Pulmonary/ Upper Respiratory Event	6.2% 4/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Cardiac disorders Atrial Fibrillation	3.1% 2/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Cardiac disorders Hypotension	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Infections and infestations Lung Infection	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Psychiatric disorders Confusion	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Apnea	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Psychiatric disorders Psychosis	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Fever	1.6% 1/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders Hypophosphatemia	9.4% 6/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment

Other adverse events

Other adverse events
Measure	Lenalidomide, Dexamethasone, Bortezomib Combination n=64 participants at risk Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
Nervous system disorders Sensory Neuropathy	53.1% 34/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Fatigue	45.3% 29/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Neutropenia	12.5% 8/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Gastrointestinal disorders Diarrhea	37.5% 24/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Muscle Pain	39.1% 25/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders Hyperglycemia	28.1% 18/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Peripheral Edema	31.2% 20/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Thrombocytopenia	10.9% 7/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Gastrointestinal disorders Constipation	29.7% 19/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Insomnia	28.1% 18/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Extremity Pain	21.9% 14/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Anemia	21.9% 14/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Gastrointestinal disorders Nausea	23.4% 15/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Blood and lymphatic system disorders Leukopenia	7.8% 5/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Nervous system disorders Neuropathic Pain	17.2% 11/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Rash/ desquamation	12.5% 8/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Dizziness	12.5% 8/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
General disorders Fever	9.4% 6/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Nervous system disorders Motor Neuropathy	10.9% 7/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Infections and infestations Infection	23.4% 15/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Endocrine disorders Anorexia	12.5% 8/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Nervous system disorders agitation	12.5% 8/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Nervous system disorders depression	10.9% 7/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Endocrine disorders hypokalemia	10.9% 7/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Nervous system disorders neurologic- other	10.9% 7/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders hypoglycemia	9.4% 6/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders joint pain	9.4% 6/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Nervous system disorders anxiety	7.8% 5/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders dyspnea	7.8% 5/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders hypomagnesemia	7.8% 5/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Eye disorders Blurred vision	7.8% 5/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Gastrointestinal disorders vomiting	7.8% 5/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders aspartate transaminase disorder	6.2% 4/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Gastrointestinal disorders dyspepsia	6.2% 4/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders nonneuropatic generalized weakness	6.2% 4/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders weight gain	6.2% 4/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders alanine aminotransferase disorder	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Gastrointestinal disorders abdominal pain	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Metabolism and nutrition disorders alkaline phosphatase disorder	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders cough	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Endocrine disorders cushingnoid appearance	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Eye disorders ocular- other	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
Ear and labyrinth disorders tinnitus	4.7% 3/64 • Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment

Additional Information

Dr. Paul Richardson

Dana-Farber Cancer Institute

Phone: 617-632-2104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60