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Thalidomide

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Bortezomib

Daratumumab

Dexamethasone acetate

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Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)

Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab

Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation

Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation

Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab

Daratumumab 16mg/kg every 8 weeks for 2 years

Philippe Moreau, Pr

The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.

This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 2-arm (2 treatment groups), multicenter study of daratumumab in participants diagnosed with previously untreated Multiple Myeloma who are eligible for high dose chemotherapy and autologous stem cell transplantation (transplantation of own bone marrow). Participants will be randomized (assigned by chance) to one of 2 treatment groups to either receive daratumumab plus bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone for induction (before transplantation) and consolidation (after transplantation) treatment. All responders will then be re-randomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with daratumumab only or observation (no treatment). The study will include a 28-Day Screening Phase, a Treatment Phase of 6 treatment cycles (each cycle is 4 weeks in duration for total period of 30 weeks), and a Follow up Phase of 2 years. The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately 5 years after the last participant is randomized in the second phase of the study. Disease assessments will be performed every 4 weeks in the first phase of the study and then every 8 weeks in the second phase of the study. Safety will be monitored throughout the study.

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma

sCR is defined by achieving CR (complete response) in addition to having a normal serum FLC (Free Light Chain) ratio and absence of clonal cells in bone marrow

Time from the date of second randomization to either progressive disease (PD) or death

time from the initial randomization to either confirmed progressive disease (PD) or death

Time from the initial randomization to confirmed progressive disease (PD) or death due to progressive disease

Proportion of participants who have achieved CR or sCR by the end of consolidation treatment

proportion of participants who have achieved MRD (minimal residual disease) negative status by the end of consolidation

proportion of participants who have achieved sCR (stringent complete response) prior to high-dose therapy/ASCT (autologous stem cell transplantation)

time from initial randomization to subsequent progression on next-line of therapy after disease progression on study treatment

HOVON - Dutch Haemato-Oncology Association

Janssen Research & Development, LLC

Intergroupe Francophone du Myelome

Antirheumatic Agents

Cyclophosphamide

Antineoplastic Agents, Alkylating

Alkylating Agents

Part 1 will be the dose titration part for cyclophosphamide. Participants will receive cyclophosphamide, bortezomib, and dexamethasone for 3 cycles. In Part 2, participants will receive cyclophosphamide (dose determined in Part 1) with pre-defined dose of bortezomib and dexamethasone for 3 cycles.

In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.

Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Janssen-Cilag G.m.b.H, Germany Clinical Trial

The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.

This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study.

A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy

Clinical Study on Induction of Remission Using Bortezomib (Vel), Cyclophosphamide (C), and Dexamethasone (D) in Patients Until 60 Years of Age With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy: (VelCD; Deutsche Studiengruppe Multiples Myelom [DSMM] XIa)

CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible

Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.

Janssen-Cilag G.m.b.H

Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles

Cyclophosphamide + Bortezomib + Dexamethasone

Age, Continuous

Between 20 and 39 years

Between 40 and 49 years

Between 50 and 60 years

>65 years

Age, Customized

Sex: Female, Male

Therapeutic Areas Director

Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).

Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)

Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations.

Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)

13q- (n=112)

t (4;14) (n=38)

17p- (n=31)

Other (n=104)

No changes (n=102)

Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).

Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)

13q- (n=92)

t (4;14) (n=34)

17p- (n=24)

Other (n=87)

No changes (n=87)

Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).

Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)

Overall Study

Lenalidomide

Panobinostat

Histone Deacetylase Inhibitors

Combination Therapy: Panobinostat, Carfilzomib, Lenalidomide, Dexamethasone (Ca-R-Pa-Diem) . Participants will receive up to 8 cycles of the combination as induction after which will proceed with consolidation therapy with transplant as per institutional standards. After transplant, participants receive maintenance with panobinostat/lenalidomide. The maintenance dose and schedule of panobinostat will be same given during induction for 1 year. The maintenance dose of lenalidomide will be 10 mg given for 21 days of 28 days cycle until disease progression.

Induction Phase: Panobinostat (dose escalation beginning at 10 mg) will be administered 3 times a week (TIW) by mouth every other week starting on day 1 of each cycle.

Maintenance Phase: Panobinostat will be administered TIW by mouth every other week starting on day 1 of each cycle. The dose of panobinostat during maintenance phase will be the same dose taken during cyce 8 of induction phase.

Induction Phase: Carfilzomib will be administered at 20 mg/m\^2 on Cycle 1 Day 1. Beginning on Cycle 1 Day 2 the carfilzomib dose will be according to the assigned level of 27 mg/m\^2 or 36 mg/m\^2. Carfilzomib will be administered twice weekly IV on Days 1,2, 8,9,15, and 16.

Carfilzomib

Induction Phase: Lenalidomide (25 mg) will be administered once-daily by mouth on Days 1-21, 25.

Maintenance Phase: Lenalidomide (10 mg) will be administered once-daily by mouth on days 1-21.

Induction Phase: Dexamethasone (20 mg) will be administered twice weekly by mouth or by IV on Days 1,2, 8, 9, 15, and 16.

Melissa Alsina, M.D.

The purpose of this study for Phase l is to determine the maximum tolerated dose of panobinostat given in combination with carfilzomib, lenalidomide, and dexamethasone in 28-day cycles as induction (initial) therapy to participants with newly diagnosed multiple myeloma.

In Phase ll, investigators will evaluate the safety (side effects) and efficacy (effectiveness) of panobinostat in combination with carfilzomib, lenalidomide, and dexamethasone.

Induction Therapy for Multiple Myeloma With Carfilzomib, Lenalidomide,Dexamethasone,Panobinostat

Phase I-II Study of Carfilzomib, Lenalidomide, Dexamethasone, and Panobinostat, Ca-R-Pa-Diem, as Induction Therapy for Newly Diagnosed, Untreated, Transplant-Eligible, Multiple Myeloma Patients

MTD of the Ca-R-Pa-Diem given in combination to newly diagnosed Multiple Myeloma patients.

Response rates by International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. sCR: CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Overall response rate will be the proportion of participants who achieved Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). Response rate determined by IMWG-URC will be calculated based on the number of participants with each of response categories (sCR, CR, VGPR, PR, and progressive disease) at each treatment cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma	NCT02541383	Multiple Myelom...	Bortezomib (VEL... Bortezomib, Tha... Daratumumab	18 Years - 65 Years	Intergroupe Francophone du Myelome
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma	NCT02541383	Multiple Myelom...	Bortezomib (VEL... Bortezomib, Tha... Daratumumab	18 Years - 65 Years	Intergroupe Francophone du Myelome
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy	NCT00833560	Multiple Myelom...	Cyclophosphamid... Bortezomib Dexamethasone	18 Years - 60 Years	Janssen-Cilag G.m.b.H
Induction Therapy for Multiple Myeloma With Carfilzomib, Lenalidomide,Dexamethasone,Panobinostat	NCT02802163	Multiple Myelom...	Panobinostat Carfilzomib Lenalidomide Dexamethasone	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Induction Therapy for Multiple Myeloma With Carfilzomib, Lenalidomide,Dexamethasone,Panobinostat	NCT02802163	Multiple Myelom...	Panobinostat Carfilzomib Lenalidomide Dexamethasone	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for untreated multiple myeloma