Trial Outcomes & Findings for Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma (NCT NCT01096810)

Results Overview

To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles). Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: \>25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), \>25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), \>25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From date of treatment until the date of first documented progression

Results posted on

2016-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	TBL 12 TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TBL 12 n=20 Participants TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Age, Continuous	58 years n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants
Bone Marrow Plasmacytosis	38 percentage of participants n=99 Participants

PRIMARY outcome

Timeframe: From date of treatment until the date of first documented progression

To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles). Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: \>25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), \>25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), \>25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause).

Outcome measures

Outcome measures
Measure	TBL 12 n=20 Participants TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Time to Progression	15 cycles Interval 2.0 to 54.0

PRIMARY outcome

Timeframe: from date of start of treatment until the date of best documented response up to date of progression

The response rate - percentage of participants with overall response. Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least \>50% reduction in SPEP, at least \>90% reduction or \<200 mg in UPEP, at least \>50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate.

Outcome measures

Outcome measures
Measure	TBL 12 n=20 Participants TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Response Rate	5 percentage of participants

SECONDARY outcome

Timeframe: Antitumor effect

Population: immunophenotyping was not performed in this study

To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis

Outcome measures

Outcome data not reported

Adverse Events

TBL 12

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TBL 12 n=20 participants at risk TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
General disorders Pneumococcal Pneumonia	5.0% 1/20 • Number of events 1

Other adverse events

Other adverse events
Measure	TBL 12 n=20 participants at risk TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
General disorders Nausea	5.0% 1/20 • Number of events 1

Additional Information

Dr. Sundar Jagannath

Mount Sinai

Phone: 2122417873

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place