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Site Operations, Sample Collection, and Biobanking

Site Operations and Sample Collection

Participating Sites and Distribution

The CoMMpass study was conducted across 90+ participating clinical sites in North America and Europe, including academic medical centers, cancer institutes, and affiliated community oncology practices. Sites were selected based on their ability to enroll newly diagnosed multiple myeloma patients, collect high-quality biospecimens, and adhere to standardized operating procedures defined by the study protocol.

All sites operated under a centralized protocol (MMRF-11-001) with harmonized requirements for patient consent, sample handling, documentation, and shipment.

Sample Acquisition Workflow

Biospecimen collection occurred at defined clinical milestones, including:

  • Baseline (pre-treatment)
  • On-study follow-up visits
  • Disease progression or relapse
  • Study discontinuation (when applicable)

At each collection timepoint, samples were obtained according to protocol-defined workflows designed to minimize variability across sites. Clinical metadata (e.g., visit date, disease status, treatment context) were captured concurrently and linked to each biospecimen via a unique MMRF subject and sample identifier.

Sample Types

The CoMMpass study collected a broad range of biospecimens to support comprehensive molecular profiling, including:

  • Bone marrow aspirates

    • CD138+ plasma cell–enriched fractions
    • Unsorted bone marrow mononuclear cells

  • Peripheral blood

    • Germline DNA (normal comparator)
    • Plasma and serum

  • Derived materials

    • DNA and RNA extracted from tumor and normal samples

These specimens enabled whole genome sequencing (WGS), whole exome sequencing (WES), RNA sequencing (RNA-seq), flow cytometry, cytogenetics/FISH, and downstream translational assays.

Standard Operating Procedures (SOPs)

All participating sites followed standardized SOPs provided by the study sponsor. These SOPs governed:

  • Sample collection volumes and container types
  • Timing from collection to processing
  • Temperature control and handling requirements
  • Labeling, barcoding, and documentation
  • Chain-of-custody tracking

Standardization across sites was critical to ensure consistency, reproducibility, and downstream comparability of molecular data.

Sample Shipment, Biobanking, and Processing

Shipping Logistics

Biospecimens were shipped from collection sites to centralized receiving and biobanking facilities using:

  • Temperature-controlled shippers (dry ice or liquid nitrogen dry shippers)
  • Predefined courier services approved by the study sponsor
  • Shipment documentation including sample manifests and temperature logs

Chain-of-custody was maintained throughout shipment to ensure sample integrity and traceability.

Receiving and Biobanking Centers

Upon receipt, samples were logged into centralized inventory systems at designated biobanking centers. Receiving procedures included:

  • Verification of sample identifiers and shipment documentation
  • Assessment of shipping conditions and temperature stability
  • Initial quality checks (volume, integrity, viability where applicable)

Samples failing predefined acceptance criteria were flagged, documented, and excluded from downstream processing when necessary.

Long-Term Storage

Accepted biospecimens were stored under controlled, long-term conditions appropriate to sample type, including:

  • Liquid nitrogen vapor phase storage
  • –80°C freezers for nucleic acids and plasma

All samples were tracked using digital inventory systems that recorded storage location, freeze-thaw history, and downstream distribution events.

Distribution to Processing Laboratories

Based on study timelines and assay requirements, biospecimens were released from biobanks to designated processing laboratories for molecular analysis.

These laboratories performed:

  • DNA and RNA extraction
  • Library preparation
  • High-throughput sequencing
  • Assay-specific quality control

Distribution was coordinated centrally to ensure alignment with sequencing batch design, data release schedules, and interim analysis milestones.

Relationship to Downstream Data Generation

The standardized site operations, shipment, and biobanking workflows established the foundation for all downstream molecular and computational analyses described in later sections of this documentation, including sequencing, bioinformatic processing, and data release.