Trial Outcomes & Findings for Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma (NCT NCT01919086)
NCT ID: NCT01919086
Last Updated: 2026-03-02
Results Overview
(defined as \> or = to PR) after 4 cycles of response-adapted sequential therapy, using bortezomib and dexamethasone (BD) followed by the addition of lenalidomide in suboptimal responders
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
after 4 cycles of response-adapted sequential therapy, up to 5 months
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
Patients With Multiple Myeloma
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Patients With Multiple Myeloma
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Patients With Multiple Myeloma
n=30 Participants
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Age, Continuous
|
76 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: after 4 cycles of response-adapted sequential therapy, up to 5 months(defined as \> or = to PR) after 4 cycles of response-adapted sequential therapy, using bortezomib and dexamethasone (BD) followed by the addition of lenalidomide in suboptimal responders
Outcome measures
| Measure |
Patients With Multiple Myeloma
n=30 Participants
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Overall Response Rate
Achieved > or = PR
|
30 Participants
|
|
Overall Response Rate
Did not achieve > or = PR
|
0 Participants
|
SECONDARY outcome
Timeframe: after 8 cycles of response-adapted sequential therapy, up to 9 monthsfor the entire population after up to 8 cycles of response-adapted sequential therapy
Outcome measures
| Measure |
Patients With Multiple Myeloma
n=30 Participants
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Overall Response Rate
Achieved >or = PR
|
30 Participants
|
|
Overall Response Rate
Did not achieve >or = PR
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to eight cycles of treatment, up to 9 monthswill be tabulated after the completion of cycle four and cycle eight (for those who would have completed 8 cycles), and the overall response rate for the entire population after up to eight cycles will be estimated and compared to the responses reported in the phase II study by Richardson et al. using the 3-drug-combination.
Outcome measures
| Measure |
Patients With Multiple Myeloma
n=30 Participants
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Response
Not Evaluable
|
2 Participants
|
|
Response
Complete Response
|
3 Participants
|
|
Response
Partial Response
|
25 Participants
|
SECONDARY outcome
Timeframe: 2 yearsBefore each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0.
Outcome measures
| Measure |
Patients With Multiple Myeloma
n=30 Participants
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Number of Participants Evaluated for Toxicity
|
30 Participants
|
SECONDARY outcome
Timeframe: Up to 7 yearswill be estimated for all patients using Kaplan-Meier methodology. This analysis will include all patients regardless of their transplantation status.
Outcome measures
| Measure |
Patients With Multiple Myeloma
n=30 Participants
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Progression-free Survival (PFS)
|
42 months
Interval 21.0 to 82.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Data were not collected due to this being a minor objective that is not crucial to the study. Resources were prioritized to primary and secondary outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Data were not collected due to this being a minor objective that is not crucial to the study. Resources were prioritized to primary and secondary outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Data were not collected due to this being a minor objective that is not crucial to the study. Resources were prioritized to primary and secondary outcomes.
QoL will be assessed in this study using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and its corresponding multiple myeloma module (EORTC QLQ-MY20).
Outcome measures
Outcome data not reported
Adverse Events
Patients With Multiple Myeloma
Serious events: 16 serious events
Other events: 28 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Patients With Multiple Myeloma
n=30 participants at risk
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
2/30 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
2/30 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
1/30 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • 2 years
|
|
Psychiatric disorders
Delirium
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
4/30 • 2 years
|
|
General disorders
Edema limbs
|
3.3%
1/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • 2 years
|
|
General disorders
Fatigue
|
6.7%
2/30 • 2 years
|
|
General disorders
Fever
|
13.3%
4/30 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • 2 years
|
|
Hepatobiliary disorders
Hepatic failure
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
2/30 • 2 years
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • 2 years
|
|
Gastrointestinal disorders
Ileus
|
3.3%
1/30 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.3%
1/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
3.3%
1/30 • 2 years
|
|
General disorders
Localized edema
|
3.3%
1/30 • 2 years
|
|
Infections and infestations
Lung infection
|
13.3%
4/30 • 2 years
|
|
General disorders
Malaise
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders- Other, specify
|
3.3%
1/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.3%
1/30 • 2 years
|
|
General disorders
Pain
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.3%
1/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
3.3%
1/30 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
1/30 • 2 years
|
|
Infections and infestations
Skin infection
|
3.3%
1/30 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
6.7%
2/30 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
3.3%
1/30 • 2 years
|
|
Nervous system disorders
Vasovagal reaction
|
3.3%
1/30 • 2 years
|
Other adverse events
| Measure |
Patients With Multiple Myeloma
n=30 participants at risk
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
|
|---|---|
|
Vascular disorders
Flushing
|
6.7%
2/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
2/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
2/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.7%
2/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.7%
2/30 • 2 years
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • 2 years
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
2/30 • 2 years
|
|
Infections and infestations
Rash pustular
|
6.7%
2/30 • 2 years
|
|
Investigations
Weight loss
|
6.7%
2/30 • 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • 2 years
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
3.3%
1/30 • 2 years
|
|
Cardiac disorders
Constrictive pericarditis
|
3.3%
1/30 • 2 years
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • 2 years
|
|
Eye disorders
Dry eye
|
3.3%
1/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other,
|
3.3%
1/30 • 2 years
|
|
General disorders
Gen disorders & admin site conditions Other, spec
|
3.3%
1/30 • 2 years
|
|
Eye disorders
Glaucoma
|
3.3%
1/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.3%
1/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
3.3%
1/30 • 2 years
|
|
Investigations
Lipase increased
|
3.3%
1/30 • 2 years
|
|
General disorders
Localized edema
|
3.3%
1/30 • 2 years
|
|
Nervous system disorders
Movements involuntary
|
3.3%
1/30 • 2 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
3.3%
1/30 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.3%
1/30 • 2 years
|
|
Nervous system disorders
Presyncope
|
3.3%
1/30 • 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.3%
1/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • 2 years
|
|
Investigations
Serum amylase increased
|
3.3%
1/30 • 2 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
3.3%
1/30 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
1/30 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
93.3%
28/30 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
90.0%
27/30 • 2 years
|
|
Investigations
Platelet count decreased
|
90.0%
27/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
86.7%
26/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
20/30 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
63.3%
19/30 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
60.0%
18/30 • 2 years
|
|
Investigations
White blood cell decreased
|
60.0%
18/30 • 2 years
|
|
General disorders
Fatigue
|
50.0%
15/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
15/30 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
15/30 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
46.7%
14/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
46.7%
14/30 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
43.3%
13/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
43.3%
13/30 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
40.0%
12/30 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
40.0%
12/30 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
36.7%
11/30 • 2 years
|
|
Investigations
Neutrophil count decreased
|
36.7%
11/30 • 2 years
|
|
Investigations
Blood bilirubin increased
|
33.3%
10/30 • 2 years
|
|
Investigations
Creatinine increased
|
33.3%
10/30 • 2 years
|
|
General disorders
Edema limbs
|
33.3%
10/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
30.0%
9/30 • 2 years
|
|
Investigations
INR increased
|
26.7%
8/30 • 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
23.3%
7/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
23.3%
7/30 • 2 years
|
|
General disorders
Pain
|
23.3%
7/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
6/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
6/30 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
5/30 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
4/30 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
4/30 • 2 years
|
|
General disorders
Fever
|
13.3%
4/30 • 2 years
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
3/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
3/30 • 2 years
|
|
Nervous system disorders
Paresthesia
|
10.0%
3/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30 • 2 years
|
|
Eye disorders
Blurred vision
|
6.7%
2/30 • 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
6.7%
2/30 • 2 years
|
|
General disorders
Chills
|
6.7%
2/30 • 2 years
|
|
Investigations
Cholesterol high
|
6.7%
2/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • 2 years
|
Additional Information
Dr. Hani Hassoun, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place