Multiple Myeloma, NeoplasmsNCT01804140

A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)

An observational study of Multiple Myeloma, Neoplasms, run by Genentech, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and analyzed from eligible patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma, Neoplasms
How many people: 662 participants
Where: 20 sitesUnited States
Study dates: Dec 2012to Sep 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma

Who may be able to join

Histologically confirmed solid tumors (excluding melanoma and papillary thyroid cancer) or multiple myeloma refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
Patients with multiple myeloma must have received at least one line of prior systemic therapy for the treatment of multiple myeloma

Who cannot join

Eastern Cooperative Oncology Group (ECOG) performance status > 2
Uncontrolled concurrent malignancy
Active or untreated CNS metastases
History of known carcinomatous meningitis
Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed)
Uncontrolled, severe medical illness or condition as defined in protocol MO28072

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Amarillo, Texas, 79106
Study site
Austin, Texas, 78705
Study site
Burbank, California, 91505
Study site
Columbia, Missouri, 65201
Study site
Dallas, Texas, 75231
Study site
Dallas, Texas, 75237
Study site
Dallas, Texas, 75246
Study site
Denton, Texas, 76210
Study site
Denver, Colorado, 80218
Study site
Las Vegas, Nevada, 89169
Study site
McAllen, Texas, 78503
Study site
Nashville, Tennessee, 37232
Study site
Ocala, Florida, 34471
Study site
Rancho Cucamonga, California, 91730
Study site
Sedona, Arizona, 86336
Study site
Spokane, Washington, 99204
Study site
Tucson, Arizona, 85704
Study site
Tyler, Texas, 75702
Study site
Woodbury, Minnesota, 55125
Study site
Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib

Conditions: Multiple Myeloma, Neoplasms
Medical subject headings: Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01804140
Study group	Role	What they receive
Cohort		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type
Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer [μm] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.
Measured: Up to 1 year
Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples
FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Sep 2013

First posted5 Mar 2013 (estimated)
Study startDec 2012
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple Myeloma, NeoplasmsStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 662 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01804140
Sponsor's protocol ID: ML28560
Status last verified: Nov 2016
First submitted: 26 Feb 2013
Last updated: 2 Nov 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingPhase 2
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Multiple Myeloma, Refractory
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)

All Multiple Myeloma, Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib
ClinicalTrials.gov ID: NCT01804140
Acronym / sponsor ID: ML28560
Conditions: Multiple Myeloma, Neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 662 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 5 Mar 2013 (estimated)
Results: Posted 31 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma

Key inclusion criteria (2 listed)

Histologically confirmed solid tumors (excluding melanoma and papillary thyroid cancer) or multiple myeloma refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
Patients with multiple myeloma must have received at least one line of prior systemic therapy for the treatment of multiple myeloma

Key exclusion criteria (6 listed)

Eastern Cooperative Oncology Group (ECOG) performance status > 2
Uncontrolled concurrent malignancy
Active or untreated CNS metastases
History of known carcinomatous meningitis
Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type
Time frame: Up to 1 year
Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer [μm] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.
Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples
Time frame: Up to 1 year
FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.

Results and safety

Results posted to the registry on 31 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Confirmed Solid Tumors or Multiple Myeloma	662	548

Primary outcome: Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type

Time frame: Up to 1 year. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Participants With Confirmed Solid Tumors or Multiple Myeloma n = 548
Breast cancer (n=85)	0 (0 to 0)
Non-small cell lung carcinoma (n=65)	3 (0.4 to 10.7)
Colorectal cancer (n=74)	11 (4.8 to 20.2)
Ovarian cancer (n=66)	0 (0 to 0)
Prostate cancer (n=21)	0 (0 to 0)
Multiple myeloma (n=31)	3 (0.1 to 16.7)
Biliary tract cancer (n=16)	6 (0.2 to 30.2)
Other cancer (n=190)	2 (0.6 to 5.3)

Population analysed: All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population.

Primary outcome: Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples

Time frame: Up to 1 year. Number. Unit: participants

Measure	Participants With Confirmed Solid Tumors or Multiple Myeloma n = 548
BRAF V600E	16
BRAF V600K	0
BRAF V600D	0
BRAF V600R	0
Other V600	0

Population analysed: All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.

Adverse events

Time frame: All adverse events that occurred up to 28 days after the biopsy was performed or those adverse events that the physician considered to have causal relationship to the biopsy performed were recorded.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Confirmed Solid Tumors or Multiple Myeloma	0 of 548 (0%)	0 of 548 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Multiple Myeloma, Neoplasms

RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingPhase 2
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Multiple Myeloma, Refractory
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Genentech, Inc.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, Neoplasms, run by Genentech, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01804140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.