Trial Outcomes & Findings for Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma (NCT NCT00478218)
NCT ID: NCT00478218
Last Updated: 2011-08-31
Results Overview
Response that was confirmed on 2 consecutive evaluations during treatment * Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * Partial Response PR): \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Duration of Treatment (up to 5 years)
Results posted on
2011-08-31
Participant Flow
Fifty-three (53) participants were recruited between July 2006 and August 2008 at Mayo Clinic.
Participant milestones
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
19
|
|
Overall Study
COMPLETED
|
34
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
n=34 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
n=19 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.5 years
n=5 Participants
|
65 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
19 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Durie Salmon Stage
Stage IA - Low Cell Mass
|
3 paricipants
n=5 Participants
|
1 paricipants
n=7 Participants
|
4 paricipants
n=5 Participants
|
|
Durie Salmon Stage
Stage IIA - Intermediate Cell Mass
|
7 paricipants
n=5 Participants
|
11 paricipants
n=7 Participants
|
18 paricipants
n=5 Participants
|
|
Durie Salmon Stage
Stage IIIA/B - High Cell Mass
|
24 paricipants
n=5 Participants
|
7 paricipants
n=7 Participants
|
31 paricipants
n=5 Participants
|
|
Parameter of Hematologic Response - Serum M-spike >= 1 g/dL
Yes
|
25 participants
n=5 Participants
|
14 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Serum M-spike >= 1 g/dL
No
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10 mg/dL
Yes
|
21 participants
n=5 Participants
|
14 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10 mg/dL
No
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Urine M-Spike >= 200 mg/24 hours
Yes
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Urine M-Spike >= 200 mg/24 hours
No
|
23 participants
n=5 Participants
|
14 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%
Yes
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%
No
|
17 participants
n=5 Participants
|
5 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of Treatment (up to 5 years)Response that was confirmed on 2 consecutive evaluations during treatment * Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * Partial Response PR): \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels
Outcome measures
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
n=34 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
n=19 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
|---|---|---|
|
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
|
28 participants
|
16 participants
|
SECONDARY outcome
Timeframe: up to 5 yearsOS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
n=34 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
n=19 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Median OS for group 1 has not been attained.
|
NA months
Median OS for group 2 has not been attained.
|
SECONDARY outcome
Timeframe: up to 5 yearsPFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.\> Progression was defined as any one or more of the following:\> An increase of 25% from lowest confirmed response in:\> * Serum M-component (absolute increase \>= 0.5g/dl)\> * Urine M-component (absolute increase \>= 200mg/24hour\> * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl\> * Bone marrow plasma cell percentage (absolute increase of \>=10%)
Outcome measures
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
n=34 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
n=19 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
|---|---|---|
|
Progression-free Survival (PFS)
|
27 months
Interval 14.0 to 32.6
|
NA months
The median PFS for group 2 has not been attained
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Participants who achieved a partial response(PR) or better were evaluable for this analysis.
Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
n=26 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
n=16 Participants
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
|---|---|---|
|
Duration of Response (DOR)
|
26.1 months
Interval 17.5 to 31.7
|
NA months
Median DOR for group 2 has not been attained.
|
Adverse Events
LCD (Cyclophosphamide 300 mg/m^2)
Serious events: 13 serious events
Other events: 34 other events
Deaths: 0 deaths
LCD (Cyclophosphamide 300 mg)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
n=34 participants at risk
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
n=19 participants at risk
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
1/34 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Death NOS
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Lung (pneumonia) infection
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Skin (cellulites) infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Creatinine
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Leukopenia
|
5.9%
2/34 • Number of events 2
|
0.00%
0/19
|
|
Investigations
Neutropenia
|
14.7%
5/34 • Number of events 5
|
0.00%
0/19
|
|
Investigations
Platelet count decreased
|
2.9%
1/34 • Number of events 2
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Ischemia-Cerebral
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Renal and urinary disorders
Renal Failure
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Thrombosis
|
8.8%
3/34 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
LCD (Cyclophosphamide 300 mg/m^2)
n=34 participants at risk
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
LCD (Cyclophosphamide 300 mg)
n=19 participants at risk
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
|
|---|---|---|
|
Investigations
Platelet count decreased
|
55.9%
19/34 • Number of events 70
|
63.2%
12/19 • Number of events 86
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/34
|
26.3%
5/19 • Number of events 13
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/34 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
3/34 • Number of events 8
|
5.3%
1/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.8%
3/34 • Number of events 7
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower weakness
|
2.9%
1/34 • Number of events 1
|
15.8%
3/19 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Extremity-upper weakness
|
2.9%
1/34 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
11.8%
4/34 • Number of events 4
|
15.8%
3/19 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Number of events 2
|
5.3%
1/19 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/34 • Number of events 2
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
2/34 • Number of events 3
|
15.8%
3/19 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
17/34 • Number of events 61
|
73.7%
14/19 • Number of events 108
|
|
Nervous system disorders
Syncope
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.9%
1/34 • Number of events 1
|
10.5%
2/19 • Number of events 3
|
|
Psychiatric disorders
Agitation
|
11.8%
4/34 • Number of events 8
|
0.00%
0/19
|
|
Psychiatric disorders
Anxiety
|
14.7%
5/34 • Number of events 8
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
5.9%
2/34 • Number of events 3
|
0.00%
0/19
|
|
Psychiatric disorders
Depression
|
11.8%
4/34 • Number of events 5
|
10.5%
2/19 • Number of events 2
|
|
Psychiatric disorders
Euphoria
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Insomnia
|
8.8%
3/34 • Number of events 12
|
21.1%
4/19 • Number of events 6
|
|
Renal and urinary disorders
Cystitis
|
17.6%
6/34 • Number of events 8
|
10.5%
2/19 • Number of events 2
|
|
Renal and urinary disorders
Renal Failure
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Reproductive system and breast disorders
Impotence
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
2/34 • Number of events 2
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
8.8%
3/34 • Number of events 5
|
21.1%
4/19 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/34
|
5.3%
1/19 • Number of events 2
|
|
Vascular disorders
Phlebitis
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Thrombosis
|
11.8%
4/34 • Number of events 5
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
41.2%
14/34 • Number of events 50
|
52.6%
10/19 • Number of events 37
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Cardiac disorders
Cardiovascular
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Cardiac disorders
Sinus bradycardia
|
2.9%
1/34 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
2/34 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
|
Eye disorders
Cataract
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • Number of events 2
|
10.5%
2/19 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea-No Colostom
|
20.6%
7/34 • Number of events 17
|
15.8%
3/19 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Number of events 5
|
0.00%
0/19
|
|
Gastrointestinal disorders
Oral cavity Mucositis/stomatitis (functional/symptomatic)
|
0.00%
0/34
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Pain-Abdominal
|
5.9%
2/34 • Number of events 2
|
0.00%
0/19
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
3/34 • Number of events 3
|
0.00%
0/19
|
|
General disorders
Edema: Limb
|
8.8%
3/34 • Number of events 5
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fatigue
|
91.2%
31/34 • Number of events 239
|
94.7%
18/19 • Number of events 174
|
|
General disorders
Fever-No ANC
|
0.00%
0/34
|
10.5%
2/19 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Respiratory tract infection
|
2.9%
1/34 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Skin (cellulites) infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Creatinine
|
2.9%
1/34 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Leukopenia
|
61.8%
21/34 • Number of events 96
|
73.7%
14/19 • Number of events 67
|
|
Investigations
Lymphopenia
|
5.9%
2/34 • Number of events 24
|
21.1%
4/19 • Number of events 24
|
|
Investigations
Neutropenia
|
91.2%
31/34 • Number of events 288
|
84.2%
16/19 • Number of events 163
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place