Trial Outcomes & Findings for Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L (NCT NCT00807599)
NCT ID: NCT00807599
Last Updated: 2019-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
2 years
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
Continue Lenalidomide and Dexamethasone
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
Not Evaluable
Participants were not randomized and are not evaluable
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
17
|
|
Overall Study
COMPLETED
|
26
|
24
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
17
|
Reasons for withdrawal
| Measure |
Continue Lenalidomide and Dexamethasone
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
Not Evaluable
Participants were not randomized and are not evaluable
|
|---|---|---|---|
|
Overall Study
Not treated on protocol study
|
0
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
5
|
|
Overall Study
Inadequate response to induction
|
0
|
0
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L
Baseline characteristics by cohort
| Measure |
Continue Lenalidomide and Dexamethasone
n=26 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
n=24 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
n=5 Participants
|
60.5 years
n=7 Participants
|
60.96 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Continue Lenalidomide and Dexamethasone
n=26 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
n=24 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
|---|---|---|
|
Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.
|
84.6 percentage of participants
Interval 70.7 to 98.5
|
83.3 percentage of participants
Interval 68.4 to 98.2
|
SECONDARY outcome
Timeframe: 2 yearsVGPR/Very Good Partial Response + CR/Complete Response (\>/= VGPR) for each study arm Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Continue Lenalidomide and Dexamethasone
n=26 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
n=24 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
|---|---|---|
|
Number of Participants With VGPR + CR Rate
>/= VGPR
|
18 Participants
|
21 Participants
|
|
Number of Participants With VGPR + CR Rate
<VGPR
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Continue Lenalidomide and Dexamethasone
n=26 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
n=24 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
|---|---|---|
|
Overall Response Rates
Stringent Complete Response
|
12 Participants
|
12 Participants
|
|
Overall Response Rates
Complete Response
|
0 Participants
|
2 Participants
|
|
Overall Response Rates
Very Good Partial Response
|
6 Participants
|
7 Participants
|
|
Overall Response Rates
Partial Response
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsOutcome measures
| Measure |
Continue Lenalidomide and Dexamethasone
n=26 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
n=24 Participants
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
|---|---|---|
|
Overall Survival
|
95.7 percentage of participants alive
Interval 87.3 to 99.9
|
90.6 percentage of participants alive
Interval 78.2 to 99.9
|
Adverse Events
Continue Lenalidomide and Dexamethasone
Serious events: 17 serious events
Other events: 26 other events
Deaths: 3 deaths
Stem Cell Transplant x 1 or x 2
Serious events: 18 serious events
Other events: 24 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Continue Lenalidomide and Dexamethasone
n=26 participants at risk
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
n=24 participants at risk
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
2/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Blood Glucose Increase
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Cardiac disorders
Cardiac disorder
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Infections and infestations
Catheter related infection
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Cardiac disorders
Chest pain
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Hepatobiliary disorders
Cholecystitis
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.4%
4/26 • Up to 4 years
|
16.7%
4/24 • Up to 4 years
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
3.8%
1/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
Infections and infestations
Infection
|
3.8%
1/26 • Up to 4 years
|
25.0%
6/24 • Up to 4 years
|
|
Blood and lymphatic system disorders
Myelodysplasia
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Cardiac disorders
Myocardial ischemia
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Investigations
Neutrophil count decreased
|
11.5%
3/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
General disorders
Pain
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Vascular disorders
Peripheral ischemia
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • Up to 4 years
|
16.7%
4/24 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Serum sodium decrease
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis lower limb
|
3.8%
1/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Vascular disorders
Thrombosis
|
7.7%
2/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
19.2%
5/26 • Up to 4 years
|
25.0%
6/24 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
General disorders
Flu-like symptoms
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Investigations
INR increased
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
General disorders
Mental Status
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Gastrointestinal disorders
Visceral arterial ischemia
|
0.00%
0/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
Other adverse events
| Measure |
Continue Lenalidomide and Dexamethasone
n=26 participants at risk
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
stem cell transplant right after collection
* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.
lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
|
Stem Cell Transplant x 1 or x 2
n=24 participants at risk
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
|
|---|---|---|
|
Investigations
ALT
|
11.5%
3/26 • Up to 4 years
|
37.5%
9/24 • Up to 4 years
|
|
Investigations
AST
|
11.5%
3/26 • Up to 4 years
|
20.8%
5/24 • Up to 4 years
|
|
Investigations
Alkaline Phosphatase
|
3.8%
1/26 • Up to 4 years
|
12.5%
3/24 • Up to 4 years
|
|
Investigations
Bilirubin
|
11.5%
3/26 • Up to 4 years
|
12.5%
3/24 • Up to 4 years
|
|
Investigations
CPK
|
11.5%
3/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
Investigations
Creatinine
|
15.4%
4/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Up to 4 years
|
16.7%
4/24 • Up to 4 years
|
|
General disorders
Edema: limb
|
7.7%
2/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
General disorders
Fatigue
|
34.6%
9/26 • Up to 4 years
|
41.7%
10/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
65.4%
17/26 • Up to 4 years
|
54.2%
13/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.7%
2/26 • Up to 4 years
|
4.2%
1/24 • Up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
76.9%
20/26 • Up to 4 years
|
79.2%
19/24 • Up to 4 years
|
|
Investigations
INR
|
15.4%
4/26 • Up to 4 years
|
12.5%
3/24 • Up to 4 years
|
|
Infections and infestations
Infection, other
|
3.8%
1/26 • Up to 4 years
|
20.8%
5/24 • Up to 4 years
|
|
Investigations
White Blood Cell
|
88.5%
23/26 • Up to 4 years
|
91.7%
22/24 • Up to 4 years
|
|
Investigations
Lymphopenia
|
88.5%
23/26 • Up to 4 years
|
91.7%
22/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Magnesium
|
11.5%
3/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Nervous system disorders
Neuropathy: Sensory
|
15.4%
4/26 • Up to 4 years
|
16.7%
4/24 • Up to 4 years
|
|
Investigations
Neutrophils/Granulocytes
|
92.3%
24/26 • Up to 4 years
|
87.5%
21/24 • Up to 4 years
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
11.5%
3/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
General disorders
Pain, Other
|
30.8%
8/26 • Up to 4 years
|
25.0%
6/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
57.7%
15/26 • Up to 4 years
|
70.8%
17/24 • Up to 4 years
|
|
Investigations
Platelets
|
65.4%
17/26 • Up to 4 years
|
87.5%
21/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
19.2%
5/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.8%
1/26 • Up to 4 years
|
29.2%
7/24 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash Desquamation
|
7.7%
2/26 • Up to 4 years
|
0.00%
0/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
4/26 • Up to 4 years
|
12.5%
3/24 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/26 • Up to 4 years
|
25.0%
6/24 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/26 • Up to 4 years
|
12.5%
3/24 • Up to 4 years
|
|
Blood and lymphatic system disorders
Febrile Neuropenia
|
0.00%
0/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
General disorders
Fever
|
0.00%
0/26 • Up to 4 years
|
16.7%
4/24 • Up to 4 years
|
|
Reproductive system and breast disorders
Pain - Pelvis
|
0.00%
0/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
|
Eye disorders
Blurred Vision
|
0.00%
0/26 • Up to 4 years
|
8.3%
2/24 • Up to 4 years
|
Additional Information
Dr. Hani Hassoun, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place