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A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma

Clinicaltrials.gov identifier NCT02773030

Recruitment Status Recruiting

First Posted May 16, 2016

Last update posted September 23, 2020

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Study Description

Brief summary:

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

Condition or Disease:Multiple Myeloma
Intervention/Treatment: Drug: CC-220
Drug: Dexamethasone
Drug: Daratumumab - 16mg/kg
Drug: Bortezomib (BTZ)
Drug: Carfilzomib
Drug: Daratumumab- 1800mg
Phase: Phase 1/Phase 2

Detailed Description

Subjects assigned to CC-220 monotherapy, who develop progressive disease (PD) will have the option to receive DEX in addition to CC-220 after consultation with the Medical Monitor. The dose of CC-220 will not be higher than the dose of CC-220 used in combination with dexamethasone in Cohort B that has been determined to be safe. Progressive disease must be confirmed in accordance with international myeloma working group (IMWG) criteria. The starting dose of DEX will be 40 mg for subjects who are ≤75 years of age and 20 mg for subjects who are >75 years of age, given once weekly. This treatment will continue until PD, unacceptable toxicity or the subject withdraws consent. For Cohorts A and B, the starting dose level of CC-220, dose level 1, is 0.3 mg. A dose level -1, of 0.15 mg, may also be evaluated if the starting dose level of 0.3 mg for 21 days of a 28-day cycle is not tolerated. For Cohorts E and F, the starting dose level of CC-220, dose level 1, is one dose level below the maximum dose for Cohort B that has been determined to be safe by the dose escalation committee (DEC) at the start of enrollment for both cohorts. For Cohort E in addition to CC-220 and DEX, daratumumab will be administered intravenously (IV) at a 16mg/kg dose. For Cohort F in addition to CC-220 and DEX, bortezomib will be administered subcutaneous (SC) at a 1.3mg/m2 dose. All subjects with a minimal response (MR) or better who discontinue study treatment in Part 1 or Part 2 of the study for a reason other than PD or withdrawal of consent from the study will be followed for response assessment every 28 days (every 21 days for Cohort F) until PD. The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. The initiation of Part 2 will begin when the RP2D is established in Part 1 in either Cohort A or Cohort B. Either cohort may begin once the RP2D is determined for each cohort independently during Part 1. All expansion decisions will be determined by the DEC after review of all safety, PK, biomarker and preliminary efficacy data, as applicable. During Part 2, the Independent Expert Reviewer will review safety data and any other data deemed relevant so that subject safety is ensured.

Study Design

Study Type: Interventional
Estimated Enrollment: 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma

Actual Study Start Date: October 2016
Estimated Primary Completion Date: June 2021
Estimated Study Completion Date: May 2027

Arms and interventions

Arm	Intervention/treatment
Experimental: Cohort A: CC-220 Monotherapy - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Experimental: Cohort B: CC-220 in combination with Dexamethasone - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Experimental: Cohort D: CC-220 in combination with Dexamethasone - Part 2 Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Experimental: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Intravenous DARA at dose 16mg/kg on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. Once the MTD and/or RP2D is determined in Cohort E (CC-220Dd), subjects will be enrolled at this dose level using SC DARA. Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous DARA at dose 1800 mg over 3 to 5 minutes on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Drug: Daratumumab - 16mg/kg Daratumumab (DARA) 16mg/kg by intravenous infusion on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. Drug: Daratumumab- 1800mg Daratumumab (DARA) 1800 mg by subcutaneous injection on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.
Experimental: Cohort F: CC-220 with DEX and bortezomib - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-14 of each 21-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, and 15 of each 21-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, and 15 of each 21-day cycle. Subcutaneous BTZ at dose 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Drug: Bortezomib (BTZ) Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.
Experimental: Cohort G1-CC-220 in combination with CFZ and DEX -Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Intravenous (IV) CFZ (Carfilzomib)administered at a starting dose of 20 mg/m2 on C1D1; and at a dose specified by cohort dose level thereafter on days 1, 8, 15 of each 28-day cycle Oral DEX (Dexamethasone) on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects ≤ 75 years old, the DEX dose will be 40 mg. For subjects > 75 years old, the DEX dose will be 20 mg	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Drug: Carfilzomib Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle.
Experimental: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle Oral DEX on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 28-day cycle. The DEX dose will be 20 mg	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Drug: Carfilzomib Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle.
Experimental: CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2 Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Experimental: CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2 Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle (Cycle 1 to 8) and from Day 1-21 of each 28-day cycle (Cycle 9 and above). Oral DEX at Cycles 1 to 8, 20 mg (≤ 75 years old) or 10 mg (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle and Cycles ≥ 9, 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-8 of each 21-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Drug: Bortezomib (BTZ) Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.
Experimental: CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2 Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle. Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Drug: Bortezomib (BTZ) Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.

Outcome Measures

Primary Outcome Measures: 1. Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment [ Time Frame: Approximately 1 year ]
Establish the maximum tolerated doses (MTDs) of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab (CC-220Dd), in combination with DEX and bortezomib (CC-220Vd), and in combination with DEX and carfilzomib (CC-220Kd)
Primary Outcome Measures: 2. Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment [ Time Frame: Approximately 1 year ]
RP2D is defined as the dose selected for phase 2 based on safety, pharmacokinetics and biomarker data from phase 1 of the study.
Primary Outcome Measures: 3. Overall response rate (ORR) of CC-220 in combination with DEX in Cohort D in Part 2 [ Time Frame: Approximately 3 years ]
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2011) in CC-220 in combination with DEX
Secondary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product
Secondary Outcome Measures: 2. Overall response rate (ORR) [ Time Frame: Approximately 3 years ]
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better
Secondary Outcome Measures: 3. Time to Response (TTR) [ Time Frame: Approximately 3 years ]
Is defined as the time from the first date of dosing of IP to the first date of documented response (partial response [PR] or greater).
Secondary Outcome Measures: 4. Duration of Response (DOR) [ Time Frame: Approximately 3 years ]
Is defined as Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD)
Secondary Outcome Measures: 5. Pharmacokinetics -AUC 0-τ [ Time Frame: Approximately 1 year ]
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
Secondary Outcome Measures: 6. Pharmacokinetics -Cmax [ Time Frame: Approximately 1 year ]
Maximum plasma concentration of drug
Secondary Outcome Measures: 7. Pharmacokinetics -Tmax [ Time Frame: Approximately 1 year ]
Time to Maximum plasma concentration of drug
Secondary Outcome Measures: 8. Pharmacokinetics -t1/2 [ Time Frame: Approximately 1 year ]
Terminal-phase elimination half life
Secondary Outcome Measures: 9. Pharmacokinetics -CLss/F [ Time Frame: Approximately 1 year ]
Apparent total plasma clearance when dosed daily
Secondary Outcome Measures: 10. Pharmacokinetics -Vss/F [ Time Frame: Approximately 1 year ]
Apparent total volume of distribution at steady state when dosed orally
Secondary Outcome Measures: 11. Progression-free Survival (PFS) [ Time Frame: Approximately 3 years ]
Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first
Secondary Outcome Measures: 12. Overall Survival (OS) in Part 2 RRMM cohorts [ Time Frame: Approximately 3 years ]
Time from first dose of IP to death due to any cause
Secondary Outcome Measures: 13. Very good partial response or better rate (VGPR) [ Time Frame: Approximately 4 years ]
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved VGPR or better

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. All subjects in RRMM cohorts must have a documented diagnosis of Multiple Myeloma and
have measurable disease defined as:

1. M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP ≥0.5 g/dL
or uPEP ≥200 mg/24 hours and/or

2. Light chain Multiple Myeloma without measurable disease in the serum or urine: serum
immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum
immunoglobulin kappa lambda free light chain ratio 2. All subjects in RRMM cohorts
must have documented disease progression on or within 60 days from the last dose of
their last myeloma therapy. Subjects who had CAR T therapy as their last myeloma
therapy must have documented disease progression.

3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 3.
Subject must have documented diagnosis with previously untreated symptomatic MM as
defined by the criteria below (Rajkumar, 2016): MM diagnostic criteria;

- Clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary
plasmacytoma

- Any one or more of the following myeloma defining events:

- One or more of the following myeloma-related organ dysfunction (at least one of
the following);

• [C] Calcium elevation (serum calcium > 0.25 mmol/L [> 1 mg/dL] higher than the
upper limit of laboratory normal or > 2.75 mmol/L [> 11 mg/dL])

• [R] Renal insufficiency (serum creatinine > 2 mg/dl [> 177 μmol/L] or
creatinine clearance < 40 ml/min) - [A] Anemia (hemoglobin 2 g/dL below the lower limit of
laboratory normal)

- [B] Bone lesions (lytic or osteopenic) one or more bone lesions on skeletal
radiography, computed tomography (CT), or positron emission tomography
(PET)/CT

- One or more of the following biomarkers of malignancy:

- Clonal bone marrow plasma cell percentage* ≥ 60%

- Abnormal serum free light-chain (FLC) ratio ≥ 100 (involved kappa) or 1 focal lesion detected by magnetic resonance imaging (MRI) (at least 5 mm
in size)

AND have measurable disease, as assessed by central laboratory, defined by any of the
following:

- Immunoglobulin (Ig)G myeloma: serum M-protein level ≥ 1.0 g/dL or urine M-protein
level ≥ 200 mg/24 hours; or

- IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL or urine
M-protein level ≥ 200 mg/24 hours; or

- Light chain multiple myeloma without measurable disease in serum or urine: serum FLC
≥ 100 mg/L and abnormal kappa lambda (κ/λ) ratio 4. Subjects in Cohort J1 are not
considered by the investigator as eligible for high-dose chemotherapy and autologous
stem cell transplantation due to:

- Age ≥65 years, OR

- In subjects <65 years: presence of important comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with autologous stem cell transplantation. 5. Subjects in Cohort J2 are considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory data. Exclusion Criteria: 1. Subject has nonsecretory multiple myeloma 2. Subjects with Plasma Cell leukemia or amyloidosis 3. Any of the following laboratory abnormalities • Absolute neutrophil count (ANC) <1,000/μL • Platelet count < 75,000/μL for Part 1. For Part 2; platelet count < 75,000/μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; otherwise platelet count 13.5 mg/dL (>3.4 mmol/L)

- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST)
or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT)≥2.0
x upper limit of normal (ULN)

- Serum total bilirubin and alkaline phosphatase >1.5 x ULN

- Subjects with serious renal impairment creatinine clearance ([CrCl] <45 mL/min) or requiring dialysis would be excluded 4. Subjects with peripheral neuropathy ≥Grade 2

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

Show 61 Study Locations

Sponsors and Collaborators

Celgene

Investigators

Study Director: April Sorrell-Taylor, MD Celgene Corporation

More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02773030 History of Changes
Other Study ID Numbers: CC-220-MM-001, U1111-1182-9200, 2016-000860-40
First Posted: May 16, 2016 Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Keywords provided by Celgene: CC-220
Efficacy
Multiple Myeloma
Relapsed
Refractory
Pharmacokinetics Safety
Relapsed and refractory multiple myeloma
Dexamethasone
Daratumumab
Bortezomib
Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell

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A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma

A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma

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Study Description

Detailed Description

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Outcome Measures

Eligibility Criteria

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