Trial Outcomes & Findings for Combination of Revlimid, Melphalan and Dexamethasone as First Line Treatment for Multiple Myeloma (NCT NCT00843310)
NCT ID: NCT00843310
Last Updated: 2017-07-19
Results Overview
Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting. Progressive Disease: requires any one or more of the following: 1. Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b 2. Urine M-component and/or (the absolute increase must be ≥200 mg/24 h 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dl. 4. Bone marrow plasma cell percentage: the absolute % must be ≥10%c 5. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas 6. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder
TERMINATED
PHASE2
8 participants
every 28 days during therapy and every month after therapy for 2 years
2017-07-19
Participant Flow
Patients were enrolled from NYU medical center and its affiliated hospitals from Dec 2008 through Apr 2011.
Total 8 patients were enrolled. One patient withdrew before the treatment started.
Participant milestones
| Measure |
ReMeDex
Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination of Revlimid, Melphalan and Dexamethasone as First Line Treatment for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
ReMeDex
n=8 Participants
Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 paticipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 paticipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 paticipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 paticipants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 paticipants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 paticipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 paticipants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 28 days during therapy and every month after therapy for 2 yearsPopulation: No data are available because data were not collected. Pi left the institution and slow accrual did not allow for sufficient data collection prior to PI leaving institution. No data were analyzed.
Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting. Progressive Disease: requires any one or more of the following: 1. Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b 2. Urine M-component and/or (the absolute increase must be ≥200 mg/24 h 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dl. 4. Bone marrow plasma cell percentage: the absolute % must be ≥10%c 5. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas 6. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder
Outcome measures
Outcome data not reported
Adverse Events
ReMeDex
Serious adverse events
| Measure |
ReMeDex
n=7 participants at risk
Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Musculoskeletal and connective tissue disorders
Pain-back
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
Other adverse events
| Measure |
ReMeDex
n=7 participants at risk
Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Investigations
Alkaline phosphatase
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Gastrointestinal disorders
Anorexia
|
42.9%
3/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
General disorders
Constitutional Symptoms-Other
|
28.6%
2/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
28.6%
2/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Vascular disorders
Edema
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
42.9%
3/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Infections and infestations
Infection without neutropenia
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-Other
|
28.6%
2/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
28.6%
2/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
General disorders
Pain-Other
|
28.6%
2/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Investigations
Platelets
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Vascular disorders
Thrombosis/embolism
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
28.6%
2/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
1/7
Only 7 out of 8 patients were treated. The percentage of affected patients was based on those 7.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place