Multiple Myeloma, Neoplasms
Conditions
Brief 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. All institutions with identified patients as defined by this screening protocol will have potential access to the separate vemurafenib protocol MO28072.
Interventions
None listed
Sponsors
Genentech, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards. | 548 |
| Total | 548 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No sampling or biopsy procedures done | 114 |
Baseline characteristics
| Characteristic | Participants With Confirmed Solid Tumors or Multiple Myeloma |
|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 12.38 |
| Gender Female | 326 Participants |
| Gender Male | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 548 |
| serious Total, serious adverse events | 0 / 548 |
Outcome results
Primary
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.
Time frame: Up to 1 year
Population: All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples | BRAF V600E | 16 participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples | BRAF V600K | 0 participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples | BRAF V600D | 0 participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples | BRAF V600R | 0 participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples | Other V600 | 0 participants |
Primary
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.
Time frame: Up to 1 year
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Breast cancer (n=85) | 0 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Non-small cell lung carcinoma (n=65) | 3 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Colorectal cancer (n=74) | 11 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Ovarian cancer (n=66) | 0 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Prostate cancer (n=21) | 0 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Multiple myeloma (n=31) | 3 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Biliary tract cancer (n=16) | 6 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Other cancer (n=190) | 2 percentage of participants |
| Participants With Confirmed Solid Tumors or Multiple Myeloma | Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type | Overall (n=540) | 3 percentage of participants |