Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Smoldering Multiple Myeloma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Vaccines

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

After receiving single low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (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 is documented.

Tecemotide (L-BLP25)

After receiving multiple low dose of cyclophosphamide, subjects will receive 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 is documented.

An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.

Single low dose cyclophosphamide

An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment plus an intravenous 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.

Multiple low dose cyclophosphamide

Medical Responsible

Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell response after vaccination. The primary purpose of this study is to ascertain whether vaccination with tecemotide (L-BLP25) induces a MUC1-specific T-cell response in slowly progressive or chemotherapy naive multiple myeloma subjects.

Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy

A Randomized, Open-label, Phase II Study With Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Either Chemotherapy-naïve, Slowly Progressive, Asymptomatic Multiple Myeloma or With Stage II/III Multiple Myeloma in Stable Response/Plateau Phase Following Anti-tumor Therapy

The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon \[IFN\] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell \[PBMC\]) with ratio to background \>=2, and ratio of background-corrected value to baseline \>=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS\[t\]=1), upon fulfilling the following criteria: Yt =\>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t \> AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).

Baseline immune response towards MUC1 was defined as an immune response towards BP25, MUC-A2 or MUC-A11 peptide stimulation which was present in at least one of the two baseline assessments; the specific immune responses at baseline were based on the averaged baseline values across the two baseline visits. Initial increase of MUC1-specific immune response was defined as an increase of MUC1-specific immune response during the primary treatment period (up to Week 9).

Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.

OCR (CR, or PR, or MR or NC or PD or NE) was defined per Blade Criteria. OCR rate (CR, or PR, or MR) was defined as the number of participants having experienced at least once a CR, PR, or MR, divided by the number of all participants. CR: negative immunofixation on serum and urine monoclonal paraprotein (M-protein), disappearance of any soft tissue plasmacytomas (STP), \<=5% plasma cells in bone marrow (BM); PR: \>=50% reduction in serum M-protein, plasma cells in BM, size of STP; \>=90% reduction of urinary M-protein in 24 hours, no increase in size/number of the lytic bone lesions (LBL). MR: 25%-49% reduction in serum M-protein, plasma cells in BM aspirate in non-secretory myeloma participants, size of STP; 50%-89% reduction in 24 h urinary light chain reaction (LCR), and no increase in size/number of LBL. PD: \>25% increase in the serum M-protein level, 24 hour urinary LCR. Increase in size of existing BL or STP, development of new BL or STP, or development of hypercalcemia

Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: \>25% increase in the level of serum monoclonal paraprotein (M-protein);\>25% increase in the 24 h urinary light chain excretion; \>25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death.

Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy were treated as censored observations at time of death.

TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.

Merck KGaA, Darmstadt, Germany

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.

Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide

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.

Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide

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.

Total

Age, Continuous

Sex: Female, Male

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

Merck KGaA Communication Center

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 in Weeks 1 and 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.

Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.

Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response

Baseline immune response

MUC1 specific immune response at Week 9

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/m\^2) 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.

Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response

HLA A01 (n=3, 7)

HLA A01 not present (n=14, 8)

HLA A02 present (n=10, 10)

HLA A02 not present (n=7, 5)

HLA A03 present (n=4, 3)

HLA A03 not present (n=13, 12)

HLA A24 present (n=7, 1)

HLA A24 not present (n=10, 14)

HLA A68 present (n=2, 3)

HLA A68 not present (n=15, 12)

HLA B07 present (n=6, 5)

HLA B07 not present (n=11, 10)

HLA B08 present (n=3, 6)

HLA B08 not present (n=14, 9)

HLA B15 present (n=4, 1)

HLA B15 not present (n=13, 14)

HLA B27 present (n=3, 2)

HLA B27 not present (n=14, 13)

HLA B35 present (n=2, 4)

HLA B35 not present (n=15, 11)

HLA B44 present (n=4, 2)

HLA B44 not present (n=13, 13)

HLA C01 present (n=1, 4)

HLA C01 not present (n=16, 11)

HLA C02 present (n=3, 1)

HLA C02 not present (n=14, 14)

HLA C03 present (n=9, 2)

HLA C03 not present (n=8, 13)

HLA C04 present (n=1, 3)

HLA C04 not present (n=16, 12)

HLA C07 present (n=12, 10)

HLA C07 not present (n=5, 5)

HLA DQB02 present (n=2, 6)

HLA DQB02 not present (n=15, 9)

HLA DQB03 present (n=11, 9)

HLA DQB03 not present (n=6, 6)

HLA DQB05 present (n=6, 2)

HLA DQB05 not present (n=11, 13)

HLA DQB06 present (n=7, 5)

HLA DQB06 not present (n=10, 10)

HLA DRB01 present (n=3, 1)

HLA DRB01 not present (n=14, 14)

HLA DRB03 present (n=2, 6)

HLA DRB03 not present (n=15, 9)

HLA DRB04 present (n=11, 6)

HLA DRB04 not present (n=6, 9)

HLA DRB11 present (n=2, 5)

HLA DRB11 not present (n=15, 10)

HLA DRB13 present (n=5, 2)

HLA DRB13 not present (n=12, 13)

HLA DRB15 present (n=5, 3)

HLA DRB15 not present (n=12, 12)

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.

Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. "n" signifies number of participants evaluable for the particular HLA type, respectively.

Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type

CR+PR+MR

Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR]

Time to Progression (TTP)

Time to Anti-tumor Therapy

TEAEs

Serious TEAEs

NCI-CTC Grade 3 and 4 TEAEs

TEAEs leading to discontinuation of treatment

ISRs

Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (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.

Overall Study

Spots Global Cancer Trial Database for Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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