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Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02928029
Recruitment Status : Terminated (Due to the changes of standard of care and the slow recruitment of participants.)
First Posted : October 7, 2016
Results First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Drug: Placebo
Drug: Bortezomib
Drug: Dexamethasone
Enrollment 7
Recruitment Details The study was conducted in 7 study centers, the first participant first visit was on 10/Feb/2017 and last participant last visit on 20/Mar/2019
Pre-assignment Details 10 participants were screened in the study; 4 participants in Cohort 1 and 6 participants in Cohort 2. 3 of these participants failed screening procedures, all for the reason "inclusion criteria not met". No participants were started in the Phase 2 part of the study prior to study termination.
Arm/Group Title Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
Hide Arm/Group Description Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
Period Title: Overall Study
Started 3 4
Completed 0 0
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             0             1
Radiological progression             1             0
Clinical progression             1             2
AE not related to clinical progression             1             1
Arm/Group Title Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone Total
Hide Arm/Group Description Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX Total of all reporting groups
Overall Number of Baseline Participants 3 4 7
Hide Baseline Analysis Population Description
Safety population included all randomized subjects who received at least one administration of study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 7 participants
65.0  (5.0) 68.3  (10.3) 66.9  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Female
1
  33.3%
2
  50.0%
3
  42.9%
Male
2
  66.7%
2
  50.0%
4
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Hispanic or Latino
0
   0.0%
1
  25.0%
1
  14.3%
Not Hispanic or Latino
3
 100.0%
3
  75.0%
6
  85.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  66.7%
2
  50.0%
4
  57.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
2
  50.0%
2
  28.6%
More than one race
1
  33.3%
0
   0.0%
1
  14.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Phase 1: MTD/RP2D Determined by the Incidence of DLTs
Hide Description Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade
Time Frame From the start of study medication through 3 weeks after administration of the second dose of radium-223 dichloride, assessed up to 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set including all participants who received at least one administration of study treatment
Arm/Group Title Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
Hide Arm/Group Description:
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
Overall Number of Participants Analyzed 3 4
Measure Type: Number
Unit of Measure: KBq/kg
NA [1]  NA [1] 
[1]
This study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined
2.Primary Outcome
Title Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Drug-related TEAEs, and Treatment-emergent Serious AE
Hide Description A treatment-emergent adverse event (TEAE) is defined as any event arising or worsening after start of study drug administration until the end of the treatment period
Time Frame From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set including all participants who received at least one administration of study treatment
Arm/Group Title Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
Hide Arm/Group Description:
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
Overall Number of Participants Analyzed 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
3
 100.0%
4
 100.0%
Any drug-related TEAE
3
 100.0%
4
 100.0%
Any treatment-emergent serious AE
2
  66.7%
1
  25.0%
3.Secondary Outcome
Title Phase 1: The Number of Subjects With Complete Response (CR) and Very Good Partial Response (VGPR)
Hide Description

Determined by International Myeloma Working Group (IMWG) uniform response criteria.

CR: Negative immunofixation of serum and urine, disappearance of any soft-tissue plasmacytomas, and <5% plasma cells in bone marrow; in patients for whom only measurable disease is by serum free light chain (FLC) level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required; 2 consecutive assessments are needed.

VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component <100 mg/24 hours (hrs); in patients for whom only measurable disease is by serum FLC level, >90% decrease in difference between involved and uninvolved FLC levels, in addition to VGPR criteria, is required; 2 consecutive assessments are needed

Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set including all participants who received at least one administration of study treatment
Arm/Group Title Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
Hide Arm/Group Description:
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
Overall Number of Participants Analyzed 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1]  NA [1] 
[1]
Participants were not evaluable per International Myeloma Working Group (IMWG) uniform response criteria
Time Frame From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radium-223 33 kBq/kg + BOR/DEX Radium-223 55 kBq/kg + BOR/DEX
Hide Arm/Group Description Subjects received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX Subjects received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX
All-Cause Mortality
Radium-223 33 kBq/kg + BOR/DEX Radium-223 55 kBq/kg + BOR/DEX
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Radium-223 33 kBq/kg + BOR/DEX Radium-223 55 kBq/kg + BOR/DEX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/4 (25.00%)    
Blood and lymphatic system disorders     
Neutropenia * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Investigations     
Neutrophil count decreased * 1  1/3 (33.33%)  4 0/4 (0.00%)  0
White blood cell count decreased * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Nervous system disorders     
Peripheral sensory neuropathy * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Spinal cord compression * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (21.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radium-223 33 kBq/kg + BOR/DEX Radium-223 55 kBq/kg + BOR/DEX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/3 (33.33%)  1 1/4 (25.00%)  1
Iron deficiency anaemia * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Neutropenia * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Thrombocytopenia * 1  0/3 (0.00%)  0 1/4 (25.00%)  11
Eye disorders     
Eye discharge * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Eyelid oedema * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Periorbital oedema * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Vision blurred * 1  0/3 (0.00%)  0 2/4 (50.00%)  2
Visual acuity reduced * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension * 1  1/3 (33.33%)  1 1/4 (25.00%)  2
Abdominal pain upper * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Constipation * 1  1/3 (33.33%)  2 3/4 (75.00%)  3
Diarrhoea * 1  1/3 (33.33%)  2 3/4 (75.00%)  3
Dry mouth * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Nausea * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Vomiting * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
General disorders     
Asthenia * 1  2/3 (66.67%)  4 2/4 (50.00%)  2
Chest pain * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Chills * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Face oedema * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Fatigue * 1  1/3 (33.33%)  1 2/4 (50.00%)  2
Injection site reaction * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Oedema peripheral * 1  2/3 (66.67%)  4 0/4 (0.00%)  0
Pain * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Infections and infestations     
Cystitis * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Gastroenteritis * 1  1/3 (33.33%)  2 0/4 (0.00%)  0
Influenza * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Rhinovirus infection * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Septic arthritis streptobacillus * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Upper respiratory tract infection * 1  0/3 (0.00%)  0 2/4 (50.00%)  2
Investigations     
Lymphocyte count decreased * 1  1/3 (33.33%)  3 0/4 (0.00%)  0
Neutrophil count decreased * 1  0/3 (0.00%)  0 2/4 (50.00%)  18
Platelet count decreased * 1  0/3 (0.00%)  0 2/4 (50.00%)  16
Weight decreased * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  2/3 (66.67%)  2 0/4 (0.00%)  0
Dehydration * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Hyperkalaemia * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Hypoglycaemia * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Back pain * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Musculoskeletal chest pain * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Musculoskeletal pain * 1  1/3 (33.33%)  1 1/4 (25.00%)  1
Myalgia * 1  0/3 (0.00%)  0 2/4 (50.00%)  2
Nervous system disorders     
Cognitive disorder * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Dizziness * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Headache * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Neuropathy peripheral * 1  1/3 (33.33%)  1 1/4 (25.00%)  1
Peripheral sensory neuropathy * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Presyncope * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Tremor * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Psychiatric disorders     
Hallucination * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Insomnia * 1  0/3 (0.00%)  0 3/4 (75.00%)  3
Renal and urinary disorders     
Dysuria * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Nocturia * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Reproductive system and breast disorders     
Pelvic pain * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Dyspnoea * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Hiccups * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Nasal congestion * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Productive cough * 1  1/3 (33.33%)  1 1/4 (25.00%)  1
Throat irritation * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Rash * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
Seborrhoeic dermatitis * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Skin exfoliation * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Skin hyperpigmentation * 1  1/3 (33.33%)  1 0/4 (0.00%)  0
Vascular disorders     
Orthostatic hypotension * 1  0/3 (0.00%)  0 1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (21.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Bayer AG
Phone: (+) 1-888-8422937
EMail: clinical-trials-contact@bayer.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02928029    
Other Study ID Numbers: 18987
2016-002438-58 ( EudraCT Number )
First Submitted: October 6, 2016
First Posted: October 7, 2016
Results First Submitted: January 19, 2020
Results First Posted: February 26, 2020
Last Update Posted: February 26, 2020