Trial Outcomes & Findings for First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade (NCT NCT01215344)
NCT ID: NCT01215344
Last Updated: 2018-05-15
Results Overview
Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
6-months post ASCT
Results posted on
2018-05-15
Participant Flow
Participants participated in this trial at Vanderbilt-Ingram Cancer Center in Nashville, TN and the Boston Baskin Cancer Group in Memphis, TN. A total of 52 people consented to take part in this study and 15 were ineligible. One participant had disease progression before beginning treatment and wasn't assigned to a treatment arm.
Participant milestones
| Measure |
VRD (VELCADE, Lenalidomide, Dexamethasone)
VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
|
VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)
VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
3
|
|
Overall Study
COMPLETED
|
23
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade
Baseline characteristics by cohort
| Measure |
VRD (VELCADE, Lenalidomide, Dexamethasone)
n=33 Participants
VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
|
VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)
n=3 Participants
VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 8.71411 • n=5 Participants
|
48 years
STANDARD_DEVIATION 4.642796 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 8.803890 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
3 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-months post ASCTPopulation: Newly diagnosed, symptomatic multiple myeloma (MM) patients. Patients were treated with induction therapy VRD followed by AHCT. MRD staus was evaluated for patients with at least partial response at the end of induction (EOI) therapy. Ten of these patients had MRD negative at EOI.
Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.
Outcome measures
| Measure |
VELCADE, Lenalidomide, Dexamethasone (VRD)
n=20 Participants
VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
|
VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)
VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
|
|---|---|---|
|
The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).
|
30 percentage of participants
Interval 11.0 to 60.0
|
—
|
SECONDARY outcome
Timeframe: up to 7 yearsPopulation: Patients with MRD status information at the EOI and day 100 (post-AHCT).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
VELCADE, Lenalidomide, Dexamethasone (VRD)
n=13 Participants
VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
|
VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)
n=7 Participants
VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
|
|---|---|---|
|
Progression Free Survival by MRD Status at Day 100.
|
2.64 years
Interval 0.73 to
The value is not estimable.
|
NA years
These values are not estimable because no event happened yet.
|
Adverse Events
VRD (VELCADE, Lenalidomide, Dexamethasone)
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VRD (VELCADE, Lenalidomide, Dexamethasone)
n=33 participants at risk
VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
|
VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)
n=3 participants at risk
VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
|
|---|---|---|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastritis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Infection with normal ANC - Esophagus
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
dehydration
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Potassium low
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastric Schwannoma
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Fever
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
GI bleed
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Elevated creatinine
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Sensory neuropathy
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash, desquamation
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
VRD (VELCADE, Lenalidomide, Dexamethasone)
n=33 participants at risk
VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
|
VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)
n=3 participants at risk
VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
42.4%
14/33 • Number of events 21
|
33.3%
1/3 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
36.4%
12/33 • Number of events 15
|
66.7%
2/3 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
9/33 • Number of events 12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
21.2%
7/33 • Number of events 7
|
100.0%
3/3 • Number of events 3
|
|
Gastrointestinal disorders
Anorexia
|
15.2%
5/33 • Number of events 6
|
0.00%
0/3
|
|
General disorders
Vomiting
|
15.2%
5/33 • Number of events 6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastritis
|
9.1%
3/33 • Number of events 4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Heartburn
|
6.1%
2/33 • Number of events 5
|
0.00%
0/3
|
|
Gastrointestinal disorders
Taste alteration
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Fatigue
|
45.5%
15/33 • Number of events 21
|
100.0%
3/3 • Number of events 5
|
|
General disorders
Fever
|
24.2%
8/33 • Number of events 8
|
33.3%
1/3 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33 • Number of events 3
|
33.3%
1/3 • Number of events 2
|
|
Investigations
Weight gain
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Investigations
Weight loss
|
6.1%
2/33 • Number of events 7
|
0.00%
0/3
|
|
Nervous system disorders
Neuropathy: sensory
|
48.5%
16/33 • Number of events 31
|
66.7%
2/3 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
15.2%
5/33 • Number of events 8
|
0.00%
0/3
|
|
Psychiatric disorders
Depression
|
9.1%
3/33 • Number of events 4
|
0.00%
0/3
|
|
Nervous system disorders
Neuropathy (motor)
|
9.1%
3/33 • Number of events 4
|
0.00%
0/3
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33
|
66.7%
2/3 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal (other)
|
21.2%
7/33 • Number of events 9
|
0.00%
0/3
|
|
Nervous system disorders
Neurological (other)
|
15.2%
5/33 • Number of events 6
|
0.00%
0/3
|
|
General disorders
Pain (other)
|
30.3%
10/33 • Number of events 12
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • Number of events 9
|
33.3%
1/3 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.1%
4/33 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
3/33 • Number of events 3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
9.1%
3/33 • Number of events 3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pain-chest wall
|
6.1%
2/33 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Nervous system disorders
neuralgia/peripheral nerve
|
6.1%
2/33 • Number of events 3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
6.1%
2/33 • Number of events 3
|
0.00%
0/3
|
|
Investigations
Metabolic/Laboratory (other)
|
12.1%
4/33 • Number of events 5
|
33.3%
1/3 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium, serum-low
|
15.2%
5/33 • Number of events 5
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Glucose high
|
6.1%
2/33 • Number of events 2
|
66.7%
2/3 • Number of events 6
|
|
Metabolism and nutrition disorders
Calcium low
|
9.1%
3/33 • Number of events 3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
6.1%
2/33 • Number of events 3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
21.2%
7/33 • Number of events 11
|
33.3%
1/3 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin, other
|
15.2%
5/33 • Number of events 9
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/33
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash, erythema multiforme
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash on hand-foot
|
0.00%
0/33
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle/soft tissue, other
|
24.2%
8/33 • Number of events 18
|
0.00%
0/3
|
|
General disorders
Gait disturbance
|
9.1%
3/33 • Number of events 3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/33
|
33.3%
1/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.2%
5/33 • Number of events 5
|
0.00%
0/3
|
|
Infections and infestations
Infection, other
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Infections and infestations
Infection with normal ANC - skin (cellulitis)
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Infections and infestations
Infection with normal ANC - Upper airway NOS
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Infections and infestations
Infection with normal ANC - Eye NOS
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Infections and infestations
Infection with normal ANC - Abdomen NOS
|
0.00%
0/33
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
27.3%
9/33 • Number of events 16
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
4/33 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory - other
|
6.1%
2/33 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus reactions
|
0.00%
0/33
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice change
|
0.00%
0/33
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Neutrophils/granulocytes
|
18.2%
6/33 • Number of events 10
|
33.3%
1/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
15.2%
5/33 • Number of events 8
|
33.3%
1/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
12.1%
4/33 • Number of events 4
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukocytes
|
9.1%
3/33 • Number of events 6
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Blood/bone marrow - other
|
6.1%
2/33 • Number of events 4
|
0.00%
0/3
|
|
General disorders
Swelling of limb
|
21.2%
7/33 • Number of events 10
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Lymphatics - other
|
9.1%
3/33 • Number of events 4
|
0.00%
0/3
|
|
Vascular disorders
Hypetension
|
12.1%
4/33 • Number of events 7
|
33.3%
1/3 • Number of events 1
|
|
Cardiac disorders
Cardiac (other)
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/33
|
66.7%
2/3 • Number of events 2
|
|
Immune system disorders
Autoimmune reaction
|
0.00%
0/33
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Blurred vision
|
9.1%
3/33 • Number of events 3
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal (other)
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary frequency
|
6.1%
2/33 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Flu-like syndrome
|
9.1%
3/33 • Number of events 3
|
0.00%
0/3
|
|
Endocrine disorders
Low thyroid function
|
0.00%
0/33
|
33.3%
1/3 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place