Baseline characteristics

Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy · Source last updated 2016-02-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

1. counts

   1. group Id

      BG000

      value

      17

   2. group Id

      BG001

      value

      17

   3. group Id

      BG002

      value

      34

   units

   Participants

groups

1. description

   Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

   id

   BG000

   title

   Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide

2. description

   Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

   id

   BG001

   title

   Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            7.26

            value

            62.5

         2. group Id

            BG001

            spread

            9.36

            value

            63.9

         3. group Id

            BG002

            spread

            8.28

            value

            63.2

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            9

         2. group Id

            BG001

            value

            10

         3. group Id

            BG002

            value

            19

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            8

         2. group Id

            BG001

            value

            7

         3. group Id

            BG002

            value

            15

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

population Description

Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice